| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00850004435052 | SA002-55 | OsteoFab 5.5mm Suture Anchor | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | OsteoFab Suture Anchor | ||
| 2 | 00850004435045 | SA002-45 | OsteoFab 4.5mm Suture Anchor | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | OsteoFab Suture Anchor | ||
| 3 | 00850004435038 | INS002-01-003 | 4mm OsteoFab Suture Anchor Awl | HWJ | Awl | 1 | OsteoFab Suture Anchor | |
| 4 | 00850004435069 | SA002-65 | OsteoFab 6.5mm Suture Anchor | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | OsteoFab Suture Anchor | ||
| 5 | 00850004435021 | INS002-01-002 | 3mm OsteoFab Suture Anchor Awl | HWJ | Awl | 1 | OsteoFab Suture Anchor | |
| 6 | 00850004435014 | INS002-01-001 | 2mm OsteoFab Suture Anchor Awl | HWJ | Awl | 1 | OsteoFab Suture Anchor | |
| 7 | 00850004435007 | INS002-02-001 | OsteoFab Suture Anchor Inserter | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | OsteoFab Suture Anchor | |
| 8 | 00810023928638 | PK623880 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 9 | 00810077245729 | PK625175 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 10 | 00810077245071 | PK625047 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 11 | 00810077245880 | PK625217 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 12 | 00810077246306 | PK625249 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 13 | 00810077244746 | PK625004 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 14 | 00810077243855 | PK624832 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 15 | 00810077243404 | PK624788 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 16 | 00810077242582 | PK624637 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 17 | 00810077242513 | PK624627 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 18 | 00810077242445 | PK624608 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 19 | 00810077242377 | PK624599 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 20 | 00810077242353 | PK624591 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 21 | 00810077242346 | PK624590 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 22 | 00810077240175 | PK624150 | KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 2 | HTR-PEKK | ||
| 23 | 00810023929031 | PK623997 | KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 2 | HTR-PEKK | ||
| 24 | 00810023929161 | PK624032 | KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 2 | HTR-PEKK | ||
| 25 | 00810077245910 | PK625170 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 26 | 00810077245903 | PK625169 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 27 | 00810077245897 | PK625216 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 28 | 00810077245217 | PK625076 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 29 | 00810077245200 | PK625078 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 30 | 00810077245194 | PK625074 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 31 | 00810077245187 | PK625070 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 32 | 00810077245583 | PK625151 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 33 | 00810077245545 | PK625141 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 34 | 00810077245767 | PK625184 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 35 | 00810077245750 | PK625181 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 36 | 00810077245743 | PK625159 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 37 | 00810077245736 | PK625179 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 38 | 00810077245712 | PK625162 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 39 | 00810077245705 | PK625142 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 40 | 00810077245699 | PK625172 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 41 | 00810077245682 | PK625163 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 42 | 00810077245675 | PK625156 | GXN,KKY | Plate, Cranioplasty, Preformed, Non-Alterable,Material, Polytetrafluoroethylene Plate, Cranioplasty, Preformed, Non-Alterable,Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 2 | HTR-PEKK | ||
| 43 | 00810077245668 | PK625129 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 44 | 00810077245651 | PK625168 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 45 | 00810077245644 | PK625160 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 46 | 00810077245088 | PK625037 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 47 | 00810077244708 | PK624995 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 48 | 00810077244692 | PK625001 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 49 | 00810077244685 | PK624959 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
| 50 | 00810077244678 | PK624992 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00866453000123 | IMP-PK | PEEK Patient Specific Cranial Implant | PK Shield | OSTEOSYMBIONICS, LLC | |
| 2 | 00866453000116 | SIMP | PMMA Patient Specific Cranial Implant (Sterile) | ClearShield (Sterile) | OSTEOSYMBIONICS, LLC | |
| 3 | 00866453000109 | IMP | PMMA Patient Specific Cranial Implant (Non-Sterile) | ClearShield (Non-Sterile) | OSTEOSYMBIONICS, LLC | |
| 4 | 00855113008098 | 171708 | 171708 | Extra Small Curved | ClearFit | LONGEVITI NEURO SOLUTIONS LLC |
| 5 | 00855113008043 | 171714 | 171714 | Complex Static Cranial Implant (Primary and Backup) | ClearFit | LONGEVITI NEURO SOLUTIONS LLC |
| 6 | 00855113008036 | 171713 | 171713 | Extra Large Static Cranial Implant (Primary and Backup | ClearFit | LONGEVITI NEURO SOLUTIONS LLC |
| 7 | 00855113008029 | 171712 | 171712 | Large Static Cranial Implant (Primary and Backup) | ClearFit | LONGEVITI NEURO SOLUTIONS LLC |
| 8 | 00855113008012 | 171711 | 171711 | Medium Static Cranial Implant (Primary and Backup) | ClearFit | LONGEVITI NEURO SOLUTIONS LLC |
| 9 | 00855113008005 | 171710 | 171710 | Small Static Cranial Implant (Primary and Backup) | ClearFit | LONGEVITI NEURO SOLUTIONS LLC |
| 10 | 00845694031257 | 219-0004 | 219-0004 | OsteoFlap Removal Kit | OsteoMed | OSTEOMED LLC |
| 11 | 00845694005531 | 219-0022-SP | 219-0022-SP | 22mm, OsteoFlap, Sterile | OsteoMed | OSTEOMED LLC |
| 12 | 00845694005524 | 219-0017-SP | 219-0017-SP | 17mm, OsteoFlap, Sterile | OsteoMed | OSTEOMED LLC |
| 13 | 00845694005500 | 219-0011-SP | 219-0011-SP | 11mm, OsteoFlap, Sterile | OsteoMed | OSTEOMED LLC |
| 14 | 00841036142049 | 75-1040-12 | 75-1040-12 | RAPIDFLAP (TM) SYSTEM | BIOMET MICROFIXATION, INC | |
| 15 | 00841036142032 | 75-1030-12 | 75-1030-12 | RAPIDFLAP (TM) SYSTEM | BIOMET MICROFIXATION, INC | |
| 16 | 00841036142025 | 75-1020-12 | 75-1020-12 | RAPIDFLAP (TM) SYSTEM | BIOMET MICROFIXATION, INC | |
| 17 | 00841036068028 | 75-1040 | 75-1040 | RAPIDFLAP (TM) SYSTEM | BIOMET MICROFIXATION, INC | |
| 18 | 00841036065492 | 75-1030 | 75-1030 | RAPIDFLAP (TM) SYSTEM | BIOMET MICROFIXATION, INC | |
| 19 | 00841036058586 | 75-1020 | 75-1020 | RAPIDFLAP (TM) SYSTEM | BIOMET MICROFIXATION, INC | |
| 20 | 00817580029877 | PEEK-IM1001 | PEEK-IM1001 | PEEK Customized Cranial Implant, SmallCSI022422-GA1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 21 | 00817580029860 | PEEK-IM1003 | PEEK-IM1003 | PEEK Customized Cranial Implant, LargeCSI012822-KL1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 22 | 00817580029853 | PEEK-IM1004 | PEEK-IM1004 | PEEK Customized Cranial Implant, X-LargeCSI021422-AC1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 23 | 00817580029846 | PEEK-IM1002 | PEEK-IM1002 | PEEK Customized Cranial Implant, MediumCSI021422-GO1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 24 | 00817580029839 | PEEK-IM1002 | PEEK-IM1002 | PEEK Customized Cranial Implant, MediumCSI021422-SR1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 25 | 00817580029822 | PEEK-IM1003 | PEEK-IM1003 | PEEK Customized Cranial Implant, LargeCSI022522-JH1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 26 | 00817580029815 | PEEK-IM1003 | PEEK-IM1003 | PEEK Customized Cranial Implant, LargeCSI021422-FH1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 27 | 00817580029808 | PEEK-IM1004 | PEEK-IM1004 | PEEK Customized Cranial Implant, X-LargeCSI022422-MF1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 28 | 00817580029792 | PEEK-IM1004 | PEEK-IM1004 | PEEK Customized Cranial Implant, X-LargeCSI022322-PM1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 29 | 00817580029785 | PEEK-IM1004 | PEEK-IM1004 | PEEK Customized Cranial Implant, X-Large & SmallCSI022222-SV1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 30 | 00817580029778 | PEEK-IM1003 | PEEK-IM1003 | PEEK Customized Cranial Implant, LargeCSI012122-RE1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 31 | 00817580029761 | PEEK-IM1004 | PEEK-IM1004 | PEEK Customized Cranial Implant, X-LargeCSI012822-BB1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 32 | 00817580029754 | PEEK-IM1004 | PEEK-IM1004 | PEEK Customized Cranial Implant, X-LargeCSI021722-AA1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 33 | 00817580029747 | PEEK-IM1004 | PEEK-IM1004 | PEEK Customized Cranial Implant, X-LargeCSI020222-SW1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 34 | 00817580029730 | PEEK-IM1004 | PEEK-IM1004 | PEEK Customized Cranial Implant, X-LargeCSI032520-NP1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 35 | 00817580029723 | PEEK-IM1004 | PEEK-IM1004 | PEEK Customized Cranial Implant, X-LargeCSI031620-CS1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 36 | 00817580029716 | PEEK-IM1004 | PEEK-IM1004 | PEEK Customized Cranial Implant, X-LargeCSI030520-JR1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 37 | 00817580029709 | PEEK-IM1002 | PEEK-IM1002 | PEEK Customized Cranial Implant, MediumCSI031120-TM1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 38 | 00817580029686 | PEEK-IM1002 | PEEK-IM1002 | PEEK Customized Cranial Implant, MediumCSI022820-SS1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 39 | 00817580029501 | PEEK-IM1001 | PEEK-IM1001 | PEEK Customized Cranial Implant, SmallCSI013020-MS1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 40 | 00817580029068 | PEEK-IM1004 | PEEK-IM1004 | PEEK Customized Cranial Implant, X-LargeCSI072221-RG1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 41 | 00817580029051 | PEEK-IM1004 | PEEK-IM1004 | PEEK Customized Cranial Implant, X-LargeCSI072221-AC1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 42 | 00817580029044 | PEEK-IM1002 | PEEK-IM1002 | PEEK Customized Cranial Implant, MediumCSI071621-RT1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 43 | 00817580029037 | PEEK-IM1002 | PEEK-IM1002 | PEEK Customized Cranial Implant, MediumCSI070621-EH1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 44 | 00817580029020 | PEEK-IM1002 | PEEK-IM1002 | PEEK Customized Cranial Implant, MediumCSI071421-DB1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 45 | 00817580029013 | PEEK-IM1002 | PEEK-IM1002 | PEEK Customized Cranial Implant, MediumCSI070621-AA1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 46 | 00817580029006 | PEEK-IM1004 | PEEK-IM1004 | PEEK Customized Cranial Implant, X-LargeCSI012119-MM3 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 47 | 00817580028993 | PEEK-IM1004 | PEEK-IM1004 | PEEK Customized Cranial Implant, X-LargeCSI062921-CC1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 48 | 00817580028887 | PEEK-IM1004 | PEEK-IM1004 | PEEK Customized Cranial Implant, X-LargeCSI060821-FC1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 49 | 00817580028870 | PEEK-IM1004 | PEEK-IM1004 | PEEK Customized Cranial Implant, X-LargeCSI060721-OI1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |
| 50 | 00817580028733 | PEEK-IM1004 | PEEK-IM1004 | PEEK Customized Cranial Implant, X-LargeCSI042720-DG1 | Kelyniam CSI | KELYNIAM GLOBAL, INC. |