No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10603295059523 | 1570-03-080 | 157003080 | SUMMIT FEMORAL STEM 12/14 TAPER CEMENTED SIZE 2 STD 97mm | JDI,LZO | Prosthesis, hip, semi-constrained, metal/polymer, cemented,Prosthesis, hip, semi | 2 | SUMMIT |
2 | 10603295253693 | 9911-07-000 | 991107000 | INFERIOR JAW DEEP | GAD | RETRACTOR | 1 | NA |
3 | 10603295384793 | 420904 | 420904 | TruMatch TIBIAL PIN GUIDE FOR USE WITH: LEFT | JWH,OOG,NJL | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL | 2 | TRUMATCH |
4 | 10603295422501 | 2500-00-794 | 250000794 | Case 2 Complete | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | NA |
5 | 10603295249023 | 96-6575 | 966575 | SPECIALIST 2 TC3 TIB INSERT STERIL TRAY INSERT | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | SPECIALIST |
6 | 10603295239062 | 96-1474A | 961474A | SIGMA STABILIZED INSERT TRIAL SOLID SIZE 6 17.5mm | HWT | TEMPLATE | 1 | SIGMA |
7 | 10603295218067 | 86-8801 | 868801 | SIGMA OVAL PAT DRILL W/HUDSON END | HWE | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | 1 | SIGMA |
8 | 10603295228356 | 9505-02-134 | 950502134 | SIGMA HIGH PERFORMANCE RP-F BALANCED AP BLOCK 1.5 | HTZ | INSTRUMENT, CUTTING, ORTHOPEDIC | 1 | SIGMA |
9 | 10603295227762 | 9505-02-060 | 950502060 | SIGMA HIGH PERFORMANCE FBT DRILL TOWER | HWT | TEMPLATE | 1 | SIGMA HIGH PERFORMANCE |
10 | 10603295216230 | 86-1374 | 861374 | P.F.C. MODULAR PLUS STEP TRIAL SZ 1.5 15mm | HWT | TEMPLATE | 1 | P.F.C. |
11 | 10603295178408 | 6020-14-000 | 602014000 | ACETABULAR EXTR CHISEL 13in | HWB | EXTRACTOR | 1 | NA |
12 | 10603295175995 | 55-7099 | 557099 | APICAL HOLE PLUG | JDL | Prosthesis, hip, semi-constrained (metal cemented acetabular component) | 3 | S-ROM |
13 | 10603295174394 | 5460-30-000 | 546030000 | CEMENT RESTRICTOR TRIAL SIZE 1 | HWT | TEMPLATE | 1 | NA |
14 | 10603295174448 | 5460-40-000 | 546040000 | CEMENT RESTRICTOR TRIAL SIZE 6 | HWT | TEMPLATE | 1 | NA |
15 | 10603295170747 | 52-1553 | 521553 | S-ROM CRUCIATE HEAD PERIPHERAL SCREW 5mm x 35mm | LPH | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | 2 | S-ROM |
16 | 10603295151760 | 2722-90-971 | 272290971 | ACCLAIM MALLET | GFJ | MALLET, SURGICAL, GENERAL & PLASTIC SURGERY | 1 | ACCLAIM |
17 | 10603295149279 | 2611-40-000 | 261140000 | EXCEL INSTRUMENT CASE COMPLETE | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | EXCEL |
18 | 10603295123415 | 2422-70-000 | 242270000 | CEMENTLESS DEL SYS CASE | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | NA |
19 | 10603295110224 | 2287-51-075 | 228751075 | LCS M1 FINISHING GUIDE SM | HWT | TEMPLATE | 1 | LCS |
20 | 10603295110361 | 2287-71-000 | 228771000 | PATELLA FACE PLATE | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA |
21 | 10603295109549 | 2277-55-000 | 227755000 | LCS FEMORAL TEMPLATE MED | HWT | TEMPLATE | 1 | LCS |
22 | 10603295102175 | 2218-90-000 | 221890000 | AB STRAIGHT INSERTER | HWR | DRIVER, PROSTHESIS | 1 | NA |
23 | 10603295104872 | 2230-44-010 | 223044010 | GLOBAL CAP HUMERAL HEAD TRIAL 44mm x 18mm | HWT | TEMPLATE | 1 | GLOBAL CAP |
24 | 10603295091257 | 2130-52-520 | 213052520 | GLOBAL AP HUMERAL HEAD TRIAL 52 x 21 | HWT | TEMPLATE | 1 | GLOBAL AP |
25 | 10603295089728 | 2128-61-070 | 212861070 | GLOBAL ADVANTAGE T-HANDLE | HTO | REAMER | 1 | GLOBAL ADVANTAGE |
26 | 10603295032823 | 1363-50-000 | 136350000 | MODULAR CATHCART FRACTURE HEAD HIP BALL 50mm OD | LZY | Prosthesis, hip, hemi-, femoral, metal ball | 2 | NA |
27 | 10603295000495 | 1011-40-055 | 101140055 | SELF TAPPING ROOF PILE SCREW 55mm | JDJ | Mesh, surgical, acetabular, hip, prosthesis | 2 | NA |
28 | 10603295000488 | 1011-40-050 | 101140050 | SELF TAPPING ROOF PILE SCREW 50mm | JDJ | Mesh, surgical, acetabular, hip, prosthesis | 2 | NA |
29 | 10603295178378 | 6020-11-000 | 602011000 | CURETTE 10mm x 17in | HTF | CURETTE | 1 | NA |
30 | 10603295178361 | 6020-10-000 | 602010000 | CURETTE 8mm x 17in | HTF | CURETTE | 1 | NA |
31 | 10603295124610 | 2443-12-000 | 244312000 | CANAL REAMER 8mm | HTO | REAMER | 1 | NA |
32 | 10603295124603 | 2443-10-000 | 244310000 | CANAL REAMER 7mm | HTO | REAMER | 1 | NA |
33 | 10603295122760 | 2421-06-000 | 242106000 | FLAT OSTEOTOME 20mm | HWM | OSTEOTOME | 1 | NA |
34 | 10603295526353 | 2999-66-724 | 299966724 | EMPHASYS MAKE TO ORDER ACETABULAR CUP INSERTER ADAPTOR | HWA | IMPACTOR | 1 | EMPHASYS |
35 | 10603295514305 | 2999-65-183 | 299965183 | MAKE TO ORDER TRI-LOCK BROACH REVERSE SZ 9 | HTQ | BROACH | 1 | NA |
36 | 10603295514299 | 2999-65-182 | 299965182 | MAKE TO ORDER TRI-LOCK BROACH REVERSE SZ 8 | HTQ | BROACH | 1 | NA |
37 | 10603295514282 | 2999-65-181 | 299965181 | MAKE TO ORDER TRI-LOCK BROACH REVERSE SZ 7 | HTQ | BROACH | 1 | NA |
38 | 10603295514275 | 2999-65-178 | 299965178 | MAKE TO ORDER TRI-LOCK BROACH REVERSE SZ 4 | HTQ | BROACH | 1 | NA |
39 | 10603295514268 | 2999-65-177 | 299965177 | MAKE TO ORDER TRI-LOCK BROACH REVERSE SZ 3 | HTQ | BROACH | 1 | NA |
40 | 10603295514251 | 2999-65-176 | 299965176 | MAKE TO ORDER TRI-LOCK BROACH REVERSE SZ 2 | HTQ | BROACH | 1 | NA |
41 | 10603295514244 | 2999-65-186 | 299965186 | MAKE TO ORDER TRI-LOCK BROACH REVERSE SZ 12 | HTQ | BROACH | 1 | NA |
42 | 10603295514237 | 2999-65-185 | 299965185 | MAKE TO ORDER TRI-LOCK BROACH REVERSE SZ 11 | HTQ | BROACH | 1 | NA |
43 | 10603295514220 | 2999-65-184 | 299965184 | MAKE TO ORDER TRI-LOCK BROACH REVERSE SZ 10 | HTQ | BROACH | 1 | NA |
44 | 10603295514213 | 2999-65-175 | 299965175 | MAKE TO ORDER TRI-LOCK BROACH REVERSE SZ 1 | HTQ | BROACH | 1 | NA |
45 | 10603295514206 | 2999-65-174 | 299965174 | MAKE TO ORDER TRI-LOCK BROACH REVERSE SZ 0 | HTQ | BROACH | 1 | NA |
46 | 10603295514190 | 2999-65-180 | 299965180 | MAKE TO ORDER TRI-LOCK BROACH REVERSE SZ 6 | HTQ | BROACH | 1 | NA |
47 | 10603295514183 | 2999-65-173 | 299965173 | MAKE TO ORDER TRI-LOCK BROACH REVERSE START | HTQ | BROACH | 1 | NA |
48 | 10603295514176 | 2999-65-179 | 299965179 | MAKE TO ORDER TRI-LOCK BROACH REVERSE SZ 5 | HTQ | BROACH | 1 | NA |
49 | 10603295248651 | 96-6521 | 966521 | M.B.T. REVISION TIBIAL BROACH HANDLE | HTQ | BROACH | 1 | NA |
50 | 10603295506188 | 2999-66-451 | 299966451 | Tissue Sparing Solutions MAKE TO ORDER DUAL OFFSET BROACH HANDLE ADAPTER FOR SLAP HAMMER | HTQ | BROACH | 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& | 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. |