Implex Corp.
Allendale, NJ, US
Implex Corp. appears in FDA device records in Allendale, NJ. FDA records list 65 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 65
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 65FDA records hold 65 510(k) clearances for Implex Corp. between 1993 and 2005. The busiest year on record is 2003, with 9. The most recent is 2005, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 3 |
| 1994 | 5 |
| 1995 | 1 |
| 1996 | 1 |
| 1997 | 6 |
| 1998 | 6 |
| 1999 | 8 |
| 2000 | 7 |
| 2001 | 5 |
| 2002 | 8 |
| 2003 | 9 |
| 2004 | 4 |
| 2005 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K051978 | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT | MQP | Substantially Equivalent | |
| K051196 | TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1 | MQP | Substantially Equivalent | |
| K040487 | TRABECULAR METAL KNEE SYSTEM AUGMENTS | MBH | Substantially Equivalent | |
| K040630 | TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ | JWH | Substantially Equivalent | |
| K040756 | THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX | FTM | Substantially Equivalent | |
| K031962 | NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS | JWH | Substantially Equivalent | |
| K033384 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ | JDK | Substantially Equivalent | |
| K032527 | HEDROCEL VERTEBRAL BODY REPLACEMENT | MQP | Substantially Equivalent | |
| K032344 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 | EZX | Substantially Equivalent | |
| K031449 | MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION | KWS | Substantially Equivalent | |
| K032282 | MODIFICATION TO HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM | EZX | Substantially Equivalent | |
| K031462 | THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS | MBH | Substantially Equivalent | |
| K031823 | HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 | MQP | Substantially Equivalent | |
| K023882 | THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM | EZX | Substantially Equivalent | |
| K024161 | NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS | JWH | Substantially Equivalent | |
| K022377 | THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306 | KWT | Substantially Equivalent | |
| K022966 | PROXILOCK HIP PROSTHESIS; SIZE 12/36 | LWJ | Substantially Equivalent | |
| K022563 | HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 | MQP | Substantially Equivalent | |
| K021967 | HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2 | MQP | Substantially Equivalent | |
| K021970 | THE TRABECULAR METAL MONOBLOCK CUP, MODELS 00-7259-0XX-28 (ZIMMER CAT. #) AND 02-293-28XX1 (IMPLEX PART #) | LPH | Substantially Equivalent | |
| K021025 | MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ | MQP | Substantially Equivalent | |
| K020295 | NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00-5886-XXYY, IMPLEX PART # 05-121-XXYY-0 | JWH | Substantially Equivalent | |
| K010378 | HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ | MQP | Substantially Equivalent | |
| K012866 | THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 | JWH | Substantially Equivalent | |
| K012507 | THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX) | LPH | Substantially Equivalent | |
| K012095 | THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX) | JWH | Substantially Equivalent | |
| K011904 | NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO) | JWH | Substantially Equivalent | |
| K004013 | IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY | JWH | Substantially Equivalent | |
| K003181 | IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ | LPH | Substantially Equivalent | |
| K001759 | HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ | JDI | Substantially Equivalent | |
| K001471 | THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ | LWJ | Substantially Equivalent | |
| K001039 | THE IMPLEX HEDROCEL MODULAR ELLIPTICAL ACETABULAR CUP | LPH | Substantially Equivalent | |
| K001307 | CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ | JWH | Substantially Equivalent | |
| K990330 | CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ | JDI | Substantially Equivalent | |
| K994076 | IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR STABILIZED TIBIAL COMPONENT 05-XXX-YYYYY | JWH | Substantially Equivalent | |
| K992409 | THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ | JDI | Substantially Equivalent | |
| K991869 | COBREX HIP STEM, MODEL 01-128-XXXXX | JDI | Substantially Equivalent | |
| K983837 | HEDROCEL ACETABULAR CAGE SYSTEM | LPH | Substantially Equivalent | |
| K990183 | IMPLEX ALUMINA FEMORAL HEAD | LZO | Substantially Equivalent | |
| K984290 | IMPLEX RADIAL HEAD REPLACEMENT SYSTEM | KWI | Substantially Equivalent | |
| K983835 | IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA | JWH | Substantially Equivalent | |
| K984291 | CONTINUUM KNEE SYSTEM COBALT CHROMIUM ALLOY TIBIAL COMPONENT | JWH | Substantially Equivalent | |
| K982751 | IMPLEX SCREW AND WASHER SYSTEM | MBI | Substantially Equivalent | |
| K980637 | IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT | JWH | Substantially Equivalent | |
| K983128 | IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY | JDI | Substantially Equivalent | |
| K982302 | IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS | JWH | Substantially Equivalent for Some Indications | |
| K981560 | IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM | JWH | Substantially Equivalent | |
| K980781 | IMPLEX CONTINUUM KNEE- HEDROCEL REVISION FEMORAL SPACERS | JWH | Substantially Equivalent | |
| K980486 | IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM | JDI | Substantially Equivalent | |
| K971705 | IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED | JDI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LZNCement Obturator
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- FTMMesh, Surgical
- EZXMesh, Surgical, Metal
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer
- JDKProsthesis, Hip, Cement Restrictor
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- HWCScrew, Fixation, Bone
- MQPSpinal Vertebral Body Replacement Device
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain