510(k) K991869
- Device
- COBREX HIP STEM, MODEL 01-128-XXXXX
- Applicant
- IMPLEX CORP.
- 510(k) number
- K991869
- Product code
- JDI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-07-14
- Date received
- 1999-06-01
- Regulation
- 888.3350
- Classification name
- Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT POGGIE
- Address
- 80 Commerce Dr. Allendale NJ US 07401 07401
FDA Registration Numbers#
- 3030412764
- 3021008900
- 3013176080
- 3006085220
- 1423662
- 3002808022
- 3009871135
- 3009760038
- 3009756327
- 1834379
- 3009475821
- 3009998573
- 3002807315
- 3015398319
- 3008572101
- 1833506
- 3020162561
- 2242737
- 3005360851
- 3014302784
- 1526534
- 3017397663
- 1030489
- 1643264
- 3002806470
- 3012725451
- 3043543260
- 3002806603
- 9613369
- 3018052045
- 9613350
- 3008868758
- 1226544
- 3002807090
- 1526350
- 3005581234
- 3003541440
- 3010363503
- 3005718816
- 3010041693
- 2245304
- 1645151
- 3019807891
- 3007200272
- 1221053
- 3009973505
- 1057425
- 3012319330
- 3011295718
- 1721676
- 1220477
- 2648920
- 2528981
- 3015542154
- 3013086329
- 3005061536
- 3009241418
- 3007913880
- 1058584
- 3010039400
- 1221763
- 3010386387
- 3014644608
- 3008812251
- 9681642
- 3010468876
- 1836357
- 8010379
- 8043792
- 3002807310
- 3001278222
- 1038671
- 3012130008
- 1020279
- 3004180226
- 1828288
- 3010178296
- 3000258338
- 1219655
- 3010132111
Source Documents#
Other 510(k) Records For Product Code JDI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253515 | Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments | Biomet Orthopedics, Inc. | 2026-08-24 |
| K253434 | OSSTM Orthopedic Salvage System | Biomet, Inc. | 2026-07-01 |
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head | Signature Orthopaedics Pty, Ltd. | 2026-03-12 |
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners | Zimmer Biomet | 2025-07-31 |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems | Smith & Nephew, Inc. | 2024-10-21 |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-08-02 |
| K240418 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-04-12 |
| K233261 | Global Modular Replacement System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2023-12-08 |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-01-26 |
| K220216 | C-Stem AMT LE Prosthesis | Depuy Ireland UC | 2022-07-22 |
| K213701 | Exeter® X3® RimFit® Cup | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-02-01 |
| K213816 | MPO Hip Instruments | Microport Orthopedics, Inc. | 2022-01-05 |
| K210842 | VerSys Cemented Revision/Calcar | Zimmer, Inc. | 2021-12-10 |
| K203815 | ELEOS Limb Salvage System with BioGrip | Onkos Surgical | 2021-06-09 |
| K203588 | ELEOS™ Limb Salvage System | Onkos Surgical | 2021-02-05 |
Legacy Summary#
summary
FDA Review#
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