No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10886982181770 | 294.767 | 294767 | 4.0MM/2.5MM SCHANZ SCREW 18MM THRD/65MM | LXT,KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COM APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE,APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT | 2 | NA |
2 | 10886982195944 | 357.25 | 35725 | SLIDE HAMMER FOR HAMMER GUIDE | FZY | HAMMER, SURGICAL | 1 | NA |
3 | 10886982195920 | 357.221 | 357221 | FEMORAL NAIL HAMMER GUIDE | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | NA | |
4 | 10886982195913 | 357.22 | 35722 | HAMMER GUIDE FOR SLIDE HAMMER | FZY | HAMMER, SURGICAL | NA | |
5 | 10886982195906 | 357.181 | 357181 | FEMORAL NAIL DRIVING ADAPTOR | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | NA | |
6 | 10886982195883 | 357.133 | 357133 | EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS | HWB | EXTRACTOR | 1 | NA |
7 | 10886982195876 | 357.128 | 357128 | 13.0MM/3.2MM TROCAR | FZX | Guide, surgical, instrument | 1 | NA |
8 | 10886982195357 | 356.309 | 356309 | 9MM TREPHINE | HWK | TREPHINE | 1 | NA |
9 | 10886982195869 | 357.127 | 357127 | 13.0MM PROTECTION SLEEVE | FZX | Guide, surgical, instrument | 1 | NA |
10 | 10886982195791 | 357.096 | 357096 | AIMING ARM FOR 6.0MM TI LOCKING SCREWS | FZX | Guide, surgical, instrument | NA | |
11 | 10886982195784 | 357.095 | 357095 | CONNECTING SCREW FOR TI DISTAL FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
12 | 10886982195777 | 357.073 | 357073 | EXTRACTION HOLDING SLEEVE FOR HIP PIN | FZX | Guide, surgical, instrument | 1 | NA |
13 | 10886982195753 | 357.055 | 357055 | SCREWDRIVER HEXAGONAL CANNULATED L365MM | HXX | SCREWDRIVER | 1 | NA |
14 | 10886982195746 | 357.054 | 357054 | T-HANDLE | HXC | WRENCH | 1 | NA |
15 | 10886982195739 | 357.052 | 357052 | TROCHANTERIC FIXATION NAIL SCREW COMPRESSION NUT | HWC,HSB | Screw, fixation, bone,ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | NA | |
16 | 10886982195722 | 357.051 | 357051 | COUPLING SCREW | HXC | WRENCH | 1 | NA |
17 | 10886982195715 | 357.047 | 357047 | 6.5MM CANNULATED DRILL BIT QC/330MM | HTW | BIT, DRILL | 1 | NA |
18 | 10886982195708 | 357.046 | 357046 | FIXATION SLEEVE | HTW,FZX | BIT, DRILL,Guide, surgical, instrument | 1 | NA |
19 | 10886982195692 | 357.039 | 357039 | 2.8MM GUIDE WIRE 350MM | JDW,JDS | PIN, FIXATION, THREADED,NAIL, FIXATION, BONE | 2 | NA |
20 | 10886982195685 | 356.982 | 356982 | 4.0MM THREE-FLUTED DRILL BIT QC/215MM/80MM CALIB | GFF,HSZ,HWE,GFA | BUR, SURGICAL, GENERAL & PLASTIC SURGERY,Instrument, surgical, orthopedic, pneum BUR, SURGICAL, GENERAL & PLASTIC SURGERY,Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment,INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT,BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | 1 | NA |
21 | 10886982195678 | 356.98 | 35698 | 4.0MM THREE-FLUTED DRILL BIT QC/270MM/95MM CALIB | GFF,HWE,GFA,HSZ | BUR, SURGICAL, GENERAL & PLASTIC SURGERY,INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-PO BUR, SURGICAL, GENERAL & PLASTIC SURGERY,INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT,BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL,Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment | 1 | NA |
22 | 10886982195654 | 356.972 | 356972 | 3.2MM THREE-FLUTED DRILL BIT QC/215MM/82MM CALIBRATION | HTW | BIT, DRILL | 1 | NA |
23 | 10886982195647 | 356.97 | 35697 | 3.2MM THREE-FLUTED DRILL BIT QC/215MM/80MM CALIB | HTW | BIT, DRILL | 1 | NA |
24 | 10886982195623 | 356.830 | 356830 | GUIDE WIRE 3.2MM FOR PFNA BLADE | FZX | Guide, surgical, instrument | 1 | NA |
25 | 10886982195616 | 356.825 | 356825 | EXTRACTION SCREW FOR PFNA BLADE | HWB | EXTRACTOR | 1 | NA |
26 | 10886982195609 | 356.717 | 356717 | GUIDE WIRE 2.8MM LENGTH 460MM WITH HOOK | HWB | EXTRACTOR | 1 | NA |
27 | 10886982195517 | 356.544 | 356544 | INSERTION BOLT FOR TI CANNULATED TIBIAL NAIL | FZX | Guide, surgical, instrument | 1 | NA |
28 | 10886982195500 | 356.543 | 356543 | EXTRACTION SCREW FOR TITANIUM TIBIAL NAIL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
29 | 10886982195494 | 356.542 | 356542 | INSERTION BOLT FOR SOLID TIBIAL NAIL | FZX | Guide, surgical, instrument | 1 | NA |
30 | 10886982195463 | 356.49 | 35649 | INSERTER-EXTRACTOR FOR TI TIBIAL & HUMERAL NAILS | HWB | EXTRACTOR | 1 | NA |
31 | 10886982195456 | 356.350 | 356350 | RATCHET GRIP | HWB | EXTRACTOR | 1 | NA |
32 | 10886982195449 | 356.340 | 356340 | DRIVE SHAFT 490MM | HWB | EXTRACTOR | 1 | NA |
33 | 10886982195432 | 356.332 | 356332 | EXTRACTOR HEAD F/12MM NAILS | HWB | EXTRACTOR | 1 | NA |
34 | 10886982195425 | 356.331 | 356331 | EXTRACTOR HEAD F/11MM NAILS | HWB | EXTRACTOR | 1 | NA |
35 | 10886982195418 | 356.330 | 356330 | EXTRACTOR HEAD F/10MM NAILS | HWB | EXTRACTOR | 1 | NA |
36 | 10886982195401 | 356.329 | 356329 | EXTRACTOR HEAD F/9MM NAILS | HWB | EXTRACTOR | 1 | NA |
37 | 10886982195395 | 356.328 | 356328 | EXTRACTOR HEAD F/8MM NAILS | HWB | EXTRACTOR | 1 | NA |
38 | 10886982195388 | 356.312 | 356312 | 12MM TREPHINE | HWK | TREPHINE | 1 | NA |
39 | 10886982195371 | 356.311 | 356311 | 11MM TREPHINE | HWK | TREPHINE | 1 | NA |
40 | 10886982195364 | 356.310 | 356310 | 10MM TREPHINE | HWK | TREPHINE | 1 | NA |
41 | 10886982195234 | 355.89 | 35589 | 6.0MM/5.0MM DRILL SLEEVE | FZX | Guide, surgical, instrument | 1 | NA |
42 | 10886982195227 | 355.88 | 35588 | 5.0MM/3.5MM DRILL SLEEVE | FZX | Guide, surgical, instrument | 1 | NA |
43 | 10886982195210 | 355.87 | 35587 | 3.5MM TROCAR | FZX | Guide, surgical, instrument | 1 | NA |
44 | 10886982195203 | 355.75 | 35575 | 8.0MM TROCAR | FZX | Guide, surgical, instrument | 1 | NA |
45 | 10886982195081 | 355.59 | 35559 | LOCKING NUT FOR 17MM-19MM UNIVERSAL FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
46 | 10886982195074 | 355.58 | 35558 | LOCKING NUT FOR 13MM-16MM UNIVERSAL FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
47 | 10886982195067 | 355.57 | 35557 | LOCKING NUT FOR 9MM-12MM UNIVERSAL FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
48 | 10886982195050 | 355.55 | 35555 | THREADED CONICAL BOLT FOR 17MM-19MM UNIV FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
49 | 10886982195043 | 355.54 | 35554 | THREADED CONICAL BOLT FOR 13MM-16MM UNIV FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
50 | 10886982195036 | 355.53 | 35553 | THREADED CONICAL BOLT FOR 9MM-12MM UNIV FEMORAL NAILS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00812337021265 | 58160-20 | Single-use disposable orthopedic manual surgical instrument set | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
2 | 00812337021258 | 58160-17 | Single-use disposable orthopedic manual surgical instrument set | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
3 | 00812337021241 | 58160-15 | Single-use disposable orthopedic manual surgical instrument set | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
4 | 00812337021234 | 58160-13 | Single-use disposable orthopedic manual surgical instrument set | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
5 | 00812337021227 | 58160-11 | Single-use disposable orthopedic manual surgical instrument set | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
6 | 00812337021210 | 58160-09 | Single-use disposable orthopedic manual surgical instrument set | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
7 | 00812337021203 | 58160-07 | Single-use disposable orthopedic manual surgical instrument sets | ProChondrix® Instrument Set | DSM BIOMEDICAL, INC. | |
8 | 00811954012694 | 6008 | 6008 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=523872# | 2.7mm Trephine Removal | INTERVENTIONAL SPINE, INC |
9 | 00810019931215 | 925-0405 | 925-0405 | BIT, TREPHINE 8.0MM 1/4 SQ | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
10 | 00810019931208 | 925-0404 | 925-0404 | BIT, TREPHINE 7.0MM 1/4 SQ | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
11 | 00810019931192 | 925-0403 | 925-0403 | BIT, TREPHINE 6.0MM 1/4 SQ | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
12 | 00810019931185 | 925-0402 | 925-0402 | BIT, TREPHINE 5.0MM 1/4 SQ | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
13 | 00810019931178 | 925-0401 | 925-0401 | BIT, TREPHINE 4.0MM 1/4 SQ | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
14 | 00810019930331 | 920-0408 | 920-0408 | BIT, TREPHINE 7.0MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
15 | 00810019930324 | 920-0407 | 920-0407 | BIT, TREPHINE 6.0MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
16 | 00810019930317 | 920-0406 | 920-0406 | BIT, TREPHINE 5.0MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
17 | 00810019930300 | 920-0405 | 920-0405 | BIT, TREPHINE 4.5MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
18 | 00810019930294 | 920-0404 | 920-0404 | BIT, TREPHINE 4.0MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
19 | 00810019930287 | 920-0403 | 920-0403 | BIT, TREPHINE 3.5MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
20 | 00810019930270 | 920-0402 | 920-0402 | BIT, TREPHINE 3.0MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
21 | 00810019930263 | 920-0401 | 920-0401 | BIT, TREPHINE 2.5MM AO | Bradshaw Medical Inc. | BRADSHAW MEDICAL, INC. |
22 | 00763000078942 | EX0817013 | TREPHINE EX0817013 | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
23 | 00721902949388 | Y8087780 | 8.0MM BONE SCREW TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
24 | 00721902949371 | Y8087775 | 7.5MM BONE SCREW TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
25 | 00721902949364 | Y8087770 | 7.0MM BONE SCREW TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
26 | 00721902949340 | Y8087760 | 6.0MM BONE SCREW TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
27 | 00721902949333 | Y8087755 | 5.5MM BONE SCREW TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
28 | 00721902949319 | Y8087750 | 5.0MM BONE SCREW TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
29 | 00721902949302 | Y8087745 | 4.5MM BONE SCREW TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
30 | 00673978153438 | X1195-001 | 13MM TREPHINE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
31 | 00673978131542 | X0199-014 | 38MM BONE HARVESTER | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
32 | 00673978075143 | 893-511 | INSTRUMENT 893-511 T HNDL TREPHINE 10MM | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
33 | 00673978075136 | 893-510 | INSTRUMENT 893-510 THNDL TREPHINE 8MM | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
34 | 00673978075129 | 893-509 | INSTRUMENT 893-509 THNDL TREPHINE 6MM | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
35 | 00673978072425 | 890-504 | ADAPTER 890-504 TREPHINE AIR DRIVE | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
36 | 00643169060272 | X0811126 | TREPHINE X0811126 3.6MM | Medtronic Reusable Instruments | MEDTRONIC SOFAMOR DANEK, INC. | |
37 | 00614950012145 | 04941001 | 04941001 | TWO PIECE TREPHINE CA SHANK W/DEPTH STOP TI 6AL 4VELI | ACE | ACE SURGICAL SUPPLY CO., INC. |
38 | 00614950012008 | 04949702ST | 04949702ST | BUR TREPHINE 49.5TL 10ID 10.9O 14CL STEP NTCH MRKS 8-10-13 TI | ACE | ACE SURGICAL SUPPLY CO., INC. |
39 | 00614950011995 | 04949702S | 04949702S | BUR TREPHINE 49.5TL 10ID 10.9OD 14CL STRYKER NOTCH | ACE | ACE SURGICAL SUPPLY CO., INC. |
40 | 00614950011988 | 04949702 | 04949702 | BUR TREPHINE 49TL 10ID 10.9OD 14CL HP MRKS 8-10-13 TI | ACE | ACE SURGICAL SUPPLY CO., INC. |
41 | 00614950011971 | 04949501ST | 04949501ST | BUR TREPHINE 49TL 6ID 6.9OD 15.7CL STEP NOTCH | ACE | ACE SURGICAL SUPPLY CO., INC. |
42 | 00614950011964 | 04949501S | 04949501S | BUR TREPHINE 49TL 6ID 6.9OD 15.7CL STRYKER NOTCH MRKS 8-10-13-15 TI | ACE | ACE SURGICAL SUPPLY CO., INC. |
43 | 00614950011957 | 04949501 | 04949501 | BUR TREPHINE 49TL 6ID 6.9OD 15.7CL HP MRKS 8-10-13-15 TI | ACE | ACE SURGICAL SUPPLY CO., INC. |
44 | 00614950011940 | 04949202ST | 04949202ST | BUR TREPHINE 47TL 4.25ID 5.1OD 18.5CL STEP NOTCH | ACE | ACE SURGICAL SUPPLY CO., INC. |
45 | 00614950011933 | 04949202S | 04949202S | BUR TREPHINE 47TL 4.25ID 5.1OD 18.5CL SN MRKS 8-10-13-15-18MM TI INTERNAL IRRIGATION | ACE | ACE SURGICAL SUPPLY CO., INC. |
46 | 00614950011926 | 04949202 | 04949202 | BUR TREPHINE 52TL 4.25ID 5.1OD 18.5CL HP MRKS:8-10-13-15-18 TI INTERNAL IRRIGATION | ACE | ACE SURGICAL SUPPLY CO., INC. |
47 | 00614950011919 | 04949201ST | 04949201ST | BUR TREPHINE 52TL 3.75ID 4.6OD 18.5CL STEP NOTCH | ACE | ACE SURGICAL SUPPLY CO., INC. |
48 | 00614950011902 | 04949201 | 04949201 | BUR TREPHINE 52TL 3.75ID 4.6OD 18.5CL HP MRKS8-10-13-15-18 TI INTERNAL IRRIGATION | ACE | ACE SURGICAL SUPPLY CO., INC. |
49 | 00614950011896 | 04948702 | 04948702 | BUR TREPHINE 32TL 10ID 10.8OD 14CL CA MRKS 8-10-13 TI INTERNAL IRRIGATION | ACE | ACE SURGICAL SUPPLY CO., INC. |
50 | 00614950011889 | 04948701 | 04948701 | BUR TREPHINE 32TL 8ID 8.9OD 14CL CA MRKS 8-10-13 TI INTERNAL IRRIGATION | ACE | ACE SURGICAL SUPPLY CO., INC. |