| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | M7161122400580 | 112240058 | Trial Bipolar Head size 58 | LXH | Orthopedic Manual Surgical Instrument | 1 | OrthoMedFlex | |
| 2 | M7161122400420 | 112240042 | Trial Bipolar Head size 42 | LXH | Orthopedic Manual Surgical Instrument | 1 | OrthoMedFlex | |
| 3 | M716AS724P0 | AS-7-24P | AS-7-24P | Cement Plug, 24mm | MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicu Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate | 2 | OrthoMedFlex, LLC |
| 4 | M716AS718P0 | AS-7-18P | AS-7-18P | Cement Plug, 18mm | MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicu Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate | 2 | OrthoMedFlex, LLC |
| 5 | M716AS712P0 | AS7-12P | AS7-12P | Cement Plug, 12mm | MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicu Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate | 2 | OrthoMedFlex, LLC |
| 6 | M716AL2401600 | AL2-40-160 | AL2-40-160 | Tryon (Logical) Liner, 50-60/68mm (Neutral) | LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | OrthoMedFlex, LLC |
| 7 | M716AL2401560 | AL2-40-156 | AL2-140-156 | Tryon (Logical) Liner, 40-56/58mm (Neutral) | LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | OrthoMedFlex, LLC |
| 8 | M716AH34400 | AH3-440 | AH3-440 | Ceramic Femoral Head, 40mm +8.0mm (XL) | LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | OrthoMedFlex, LLC |
| 9 | M716AH33400 | AH3-340 | AH3-340 | Cermaic Femoral Head, 40mm +4.0mm (L) | LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | OrthoMedFlex, LLC |
| 10 | M716AH32400 | AH3-240 | AH3-240 | Ceramic Femoral Head, 40mm +0.0mm (M) | LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | OrthoMedFlex, LLC |
| 11 | M716AH31400 | AH3-140 | AH3-140 | Ceramic Femoral Head, 40mm -4.0mm (S) | LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | OrthoMedFlex, LLC |
| 12 | M716AH15400 | AH1-540 | AH1-540 | Femoral Head, SIZE 40mm (XL) CoCr Alloy (+10mm) | LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | OrthoMedFlex, LLC |
| 13 | M716AH14400 | AH1-440 | AH1-440 | Femoral Head, SIZE 40mm (XL) CoCr Alloy | LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | OrthoMedFlex, LLC |
| 14 | M716AH13400 | AH1-340 | AH1-340 | Femoral Head SIZE 40mm, (L) CoCr Alloy | LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | OrthoMedFlex, LLC |
| 15 | M716AH12400 | AH1-240 | AH1-240 | Femoral Head, SIZE 40mm (M) CoCr Alloy | LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | OrthoMedFlex, LLC |
| 16 | M716AH11400 | AH1-140 | AH1-140 | Femoral Head, SIZE 40mm, (S) CoCr Alloy | LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | OrthoMedFlex, LLC |
| 17 | M7161122800370 | 112-28-0037 | 112-28-0037 | Stepped Reamer | HTO | Reamer | 1 | OrthoMedFlex, LLC |
| 18 | M7161121584600 | 112-15-8460 | 112-15-8460 | Trial Liner, 40/60-68E (+4 10° Hooded Lateralised) | LXH | Orthopedic Manual Surgical Instrument | 1 | OrthoMedFlex, LLC |
| 19 | M7161121584560 | 112-15-8456 | 112-15-8456 | Trial Liner, 40/56-58D (+4 10° Hooded Lateralised) | LXH | Orthopedic Manual Surgical Instrument | 1 | OrthoMedFlex, LLC |
| 20 | M7161121574600 | 112-15-7460 | 112-15-7460 | Trial Liner, 40/60-68E (+4 Neutral Lateralised) | LXH | Orthopedic Manual Surgical Instrument | 1 | OrthoMedFlex, LLC |
| 21 | M7161121574560 | 112-15-7456 | 112-15-7456 | Trial Liner, 40/56-58D (+4 Neutral Lateralised) | LXH | Orthopedic Manual Surgical Instrument | 1 | OrthoMedFlex, LLC |
| 22 | M7161121532680 | 112-153-268 | 112-153-268 | Crossbar Acetabular Reamer - 68mm | HTO | Reamer | 1 | OrthoMedFlex, LLC |
| 23 | M7161121532670 | 112-153-267 | 112-153-267 | Crossbar Acetabular Reamer - 67mm | HTO | Reamer | 1 | OrthoMedFlex, LLC |
| 24 | M7161121532660 | 112-153-266 | 112-153-266 | Crossbar Acetabular Reamer - 66mm | HTO | Reamer | 1 | OrthoMedFlex, LLC |
| 25 | M7161121532650 | 112-153-265 | 112-153-265 | Crossbar Acetabular Reamer - 65mm | HTO | Reamer | 1 | OrthoMedFlex, LLC |
| 26 | M7161121532640 | 112-153-264 | 112-153-264 | Crossbar Acetabular Reamer - 64mm | HTO | Reamer | 1 | OrthoMedFlex, LLC |
| 27 | M7161121532630 | 112-153-263 | 112-153-263 | Crossbar Acetabular Reamer - 63mm | HTO | Reamer | 1 | OrthoMedFlex, LLC |
| 28 | M7161121532620 | 112-153-262 | 112-153-262 | HTO | Reamer | 1 | OrthoMedFlex, LLC | |
| 29 | M7161121532610 | 112-153-261 | 112-153-261 | Crossbar Acetabular Reamer - 61mm | HTO | Reamer | 1 | OrthoMedFlex, LLC |
| 30 | M7161121532600 | 112-153-260 | 112-153-260 | Crossbar Acetabular Reamer - 60mm | HTO | Reamer | 1 | OrthoMedFlex, LLC |
| 31 | M7161121532590 | 112-153-259 | 112-153-259 | Crossbar Acetabular Reamer - 59mm | HTO | Reamer | 1 | OrthoMedFlex, LLC |
| 32 | M7161121532580 | 112-153-258 | 112-153-258 | Crossbar Acetabular Reamer - 58mm | HTO | Reamer | 1 | OrthoMedFlex, LLC |
| 33 | M7161121532570 | 112-153-257 | 112-153-257 | Crossbar Acetabular Reamer - 57mm | HTO | Reamer | 1 | OrthoMedFlex, LLC |
| 34 | M7161121532560 | 112-153-256 | 112-153-256 | Crossbar Acetabular Reamer - 56mm | HTO | Reamer | 1 | OrthoMedFlex, LLC |
| 35 | M7161121525280 | 112-152-528 | 112-152-528 | Trial Liner, 40/60-68E (20 degree Hooded) | LXH | Orthopedic Manual Surgical Instrument | 1 | OrthoMedFlex, LLC |
| 36 | M7161121525270 | 112-152-527 | 112-152-527 | Trial Liner, 40/56-58D (20 degree Hooded) | LXH | Orthopedic Manual Surgical Instrument | 1 | OrthoMedFlex, LLC |
| 37 | M7161121521670 | 112-152-167 | 112-152-167 | Trial Liner, 40/60-68E (Neutral) | LXH | Orthopedic Manual Surgical Instrument | 1 | OrthoMedFlex, LLC |
| 38 | M7161121521660 | 112-152-166 | 112-152-166 | Trial Liner, 40/56-58D (Neutral) | LXH | Orthopedic Manual Surgical Instrument | 1 | OrthoMedFlex, LLC |
| 39 | M7161121521430 | 112-152-143 | 112-152-143 | Trial Liner, 40/60-68E (10 degree Hooded) | LXH | Orthopedic Manual Surgical Instrument | 1 | OrthoMedFlex, LLC |
| 40 | M7161121521420 | 112-152-142 | 112-152-142 | Trial Liner, 40/56-58D (10 degree Hooded) | LXH | Orthopedic Manual Surgical Instrument | 1 | OrthoMedFlex, LLC |
| 41 | M7161111912010 | 111-19-1201 | 111-19-1201 | Orion Stem, H/O (Lateralized), - Size 12 | LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | OrthoMedFlex, LLC |
| 42 | M7161111912000 | 111191200 | 111-19-1200 | Orion Stem, Standard Offset, Size 12 | LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | OrthoMedFlex, LLC |
| 43 | M7161111910010 | 111-19-1001 | 111-19-1001 | Orion Stem, H/O (Lateralized), - Size 10 | LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | OrthoMedFlex, LLC |
| 44 | M7161111910000 | 111-19-1000 | 111-19-1000 | Orion Stem, Standard Offset, Size 10 | LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | OrthoMedFlex, LLC |
| 45 | M7161111909010 | 111-19-0901 | 111-19-0901 | Orion Stem, H/O (Lateralized), - Size 9 | LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | OrthoMedFlex, LLC |
| 46 | M7161111909000 | 111-19-0900 | 111-19-0900 | Orion Stem, Standard Offset, Size 9 | LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | OrthoMedFlex, LLC |
| 47 | M7161111526440 | 111-152-644 | 111-152-644 | Ceramic Femoral Head, 40mm +8mm (XL) | LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | OrthoMedFlex, LLC |
| 48 | M7161111292010 | 111-12-9201 | 111-12-9201 | Tryon (Logical) Liner, Constrained Assembly B | LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | OrthoMedFlex, LLC |
| 49 | M716101661020 | 101-661-02 | 101-661-02 | Non-Cemented Stem Magazine Insert - Orion | FSM | Tray, Surgical, Instrument | 1 | OrthoMedFlex, LLC |
| 50 | M716101661010 | 101-661-01 | 101-661-01 | Non-Cemented Stem Magazine Insert - Kratos | FSM | Tray, Surgical, Instrument | 1 | OrthoMedFlex, LLC |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 10080196016747 | MSN10011 | MSN10011 | DRILL BIT, CANN, AO/QC, HOOK SCRW, 3.0MM | MEDLINEUNITE | MEDLINE INDUSTRIES, INC. |
| 2 | 10080196013128 | MPN50012 | MPN50012 | TISSUE PROTECTOR, 2.8MM/3.5MM | PENDING | MEDLINE INDUSTRIES, INC. |
| 3 | 10080196013111 | MPN50011 | MPN50011 | TISSUE PROTECTOR, 2.0MM/2.8MM | PENDING | MEDLINE INDUSTRIES, INC. |
| 4 | 10080196012671 | MPN50006 | MPN50006 | PERIOSTEAL ELEVATOR | MEDLINEUNITE | MEDLINE INDUSTRIES, INC. |
| 5 | 09421028116817 | ENZUGRIP | ENZUGRIP | A reusable manual surgical instrument intended to be used during an orthopaedic A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure | Microport Broach Handle - Removable Grip | ENZTEC LIMITED |
| 6 | 09421028116800 | ATCENZN1 | ATCENZN1 | A reusable manual surgical instrument intended to be used during an orthopaedic A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure | Microport Single Offset Broach Handle | ENZTEC LIMITED |
| 7 | 09421028116442 | LET30220T | LET30220T | Intended to be used for the insertion of spinal implants into the spinal space d Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery. | CONDUIT LLIF Slide Inserter 12-14mm | ENZTEC LIMITED |
| 8 | 09421028116435 | LET30210T | LET30210T | Intended to be used for the insertion of spinal implants into the spinal space d Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery. | CONDUIT LLIF Slide Inserter 8-10mm | ENZTEC LIMITED |
| 9 | 09421028116374 | 9095.11.013 | 9095.11.013 | A reusable manual surgical instrument intended to be used during an orthopaedic A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure | Dual Offset Broach Handle F1 Connection - Right | ENZTEC LIMITED |
| 10 | 09421028116367 | 9095.11.014 | 9095.11.014 | A reusable manual surgical instrument intended to be used during an orthopaedic A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure | Dual Offset Broach Handle F1 Connection - Left | ENZTEC LIMITED |
| 11 | 09421028116343 | 000-0563 | 000-0563 | A reusable manual surgical instrument intended to be used during an orthopaedic A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure | Fine Adjustment Cutting Guide - Mini Screw Driver | ENZTEC LIMITED |
| 12 | 09421028114202 | ATCENZR2 | ATCENZR2 | A reusable manual surgical instrument intended to be used during an orthopaedic A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure | Microport Double Offset Broach Handle - Right | ENZTEC LIMITED |
| 13 | 09421028114196 | ATCENZL2 | ATCENZL2 | A reusable manual surgical instrument intended to be used during an orthopaedic A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure | Microport Double Offset Broach Handle - Left | ENZTEC LIMITED |
| 14 | 09421028113465 | 72205272 | 72205272 | Intended to be used for the preparation and pre-tensioning of single tendon graf Intended to be used for the preparation and pre-tensioning of single tendon grafts for ligament reconstruction | X-Wing Sliding Base | ENZTEC LIMITED |
| 15 | 09421028113458 | 72205271 | 72205271 | Intended to be used for the preparation and pre-tensioning of single tendon graf Intended to be used for the preparation and pre-tensioning of single tendon grafts for ligament reconstruction | X-Wing Tensioner | ENZTEC LIMITED |
| 16 | 09421028113441 | 72205270 | 72205270 | Intended to be used for the preparation and pre-tensioning of single tendon graf Intended to be used for the preparation and pre-tensioning of single tendon grafts for ligament reconstruction. | X-Wing Base | ENZTEC LIMITED |
| 17 | 09421028111959 | 72205274 | 72205274 | Intended to be used for the preparation and pre-tensioning of single tendon graf Intended to be used for the preparation and pre-tensioning of single tendon grafts for ligament reconstruction | Button Holder - Suture Management | ENZTEC LIMITED |
| 18 | 09421028111942 | 72205273 | 72205273 | Intended to be used for the preparation and pre-tensioning of single tendon graf Intended to be used for the preparation and pre-tensioning of single tendon grafts for ligament reconstruction | Button Holder | ENZTEC LIMITED |
| 19 | 09421028111669 | 9095.11.002 | 9095.11.002 | A reusable manual surgical instrument intended to be used during an orthopaedic A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure | HMAX Dual Offset Broach Handle Right | ENZTEC LIMITED |
| 20 | 09421028111652 | 9095.11.003 | 9095.11.003 | A reusable manual surgical instrument intended to be used during an orthopaedic A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure | HMAX Dual Offset Broach Handle Left | ENZTEC LIMITED |
| 21 | 09421028111218 | 4240-4303 | 4240-4303 | A reusable manual surgical instrument intended to be used during an orthopaedic A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure | Enztec Patella Shim - 3mm | ENZTEC LIMITED |
| 22 | 09421028111201 | 4240-4302 | 4240-4302 | A reusable manual surgical instrument intended to be used during an orthopaedic A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure | Enztec Patella Shim - 2mm | ENZTEC LIMITED |
| 23 | 09421028111195 | 4240-4301 | 4240-4301 | A reusable manual surgical instrument intended to be used during an orthopaedic A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure | Enztec Patella Shim - 1mm | ENZTEC LIMITED |
| 24 | 09353903009016 | APN000265 | NXLH/1 | FO Large Quick Coupling Ratcheting Surgical Handle 1/pkg | FO NX Nail System | FIELD ORTHOPAEDICS PTY LTD |
| 25 | 09353903002666 | CPN000052 | BTSC00043 | 2.0 FO Guide Sleeve | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 26 | 09353903002659 | CPN000051 | BTSC00042 | 1.6 FO Guide Sleeve | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 27 | 09353903002642 | CPN000050 | BTSC00041 | 1.2 FO Guide Sleeve | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 28 | 09353903002635 | CPN000049 | BTSC00040 | 1.0 FO Guide Sleeve | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 29 | 09353903002628 | CPN000048 | BTSC00039 | 0.8 FO Guide Sleeve | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 30 | 09353903002611 | CPN000047 | BTSC00038 | 0.6 FO Guide Sleeve | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 31 | 09353903002543 | SPN000005 | BTSC00031 | FO Soft Tissue Protector | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 32 | 09353903002536 | SPN000004 | BTSC00030 | FO Surgical Handle, Quick Coupling | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 33 | 09353903002529 | CPN000029 | BTSC00029 | FO Micro Hex Driver (Cannulated) | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 34 | 09353903001799 | CPN000059 | BTSC00076 | 0.6mm Wire Collet Insert | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 35 | 09353903001782 | CPN000058 | BTSC00075 | 0.6mm Pin Collet Insert | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 36 | 09353903000426 | FOGS-0020 | FOGS-0020/1 | 2.0 FO Guide Sleeve | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 37 | 09353903000419 | FOGS-0016 | FOGS-0016/1 | 1.6 FO Guide Sleeve | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 38 | 09353903000402 | FOGS-0012 | FOGS-0012/1 | 1.2 FO Guide Sleeve | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 39 | 09353903000396 | FOGS-0010 | FOGS-0010/1 | 1.0 FO Guide Sleeve | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 40 | 09353903000389 | FOGS-0008 | FOGS-0008/1 | 0.8 FO Guide Sleeve | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 41 | 09353903000372 | FOGS-0006 | FOGS-0006/1 | 0.6 FO Guide Sleeve | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 42 | 09353903000303 | MSTP-0000 | MSTP-0000/1 | FO Soft Tissue Protector | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 43 | 09353903000297 | MSHD-0000 | MSHD-0000/1 | FO Surgical Handle, Quick Coupling | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 44 | 09353903000280 | MSHX-0000 | MSHX-0000/1 | FO Micro Hex Driver (Cannulated) | FO Micro Screw System | FIELD ORTHOPAEDICS PTY LTD |
| 45 | 09348215113308 | 199-112-172 | Cup Impactor | SIGNATURE ORTHOPAEDICS PTY LTD | ||
| 46 | 09348215109448 | 112-172-915 | World Cup Curved Inserter - Tip | SIGNATURE ORTHOPAEDICS PTY LTD | ||
| 47 | 09348215105228 | 111-45-2012 | Everglade Broach | SIGNATURE ORTHOPAEDICS PTY LTD | ||
| 48 | 09348215105211 | 111-45-2011 | Everglade Broach | SIGNATURE ORTHOPAEDICS PTY LTD | ||
| 49 | 09348215105204 | 111-45-2010 | Everglade Broach | SIGNATURE ORTHOPAEDICS PTY LTD | ||
| 50 | 09348215105198 | 111-45-2009 | Everglade Broach | SIGNATURE ORTHOPAEDICS PTY LTD |