510(k) K972792
- Device
- DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS
- Applicant
- HOWMEDICA CORP.
- 510(k) number
- K972792
- Product code
- JDI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-10-16
- Date received
- 1997-07-28
- Regulation
- 888.3350
- Classification name
- Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- FRANK MAAS
- Address
- 359 Veterans Blvd. Rutherford NJ US 07070 07070
FDA Registration Numbers#
- 3008812251
- 3010041993
- 3007923096
- 3010386387
- 3043543260
- 3007740680
- 3010120135
- 3004748528
- 1721676
- 3005581234
- 1722511
- 3011274144
- 1020279
- 3005061536
- 3009760038
- 1219655
- 1423662
- 3008395353
- 3010097171
- 3011170410
- 1835251
- 3011683674
- 3003541440
- 2246552
- 3006946279
- 3020155054
- 3012130008
- 3023852420
- 1833920
- 3010163695
- 3014302784
- 3001278222
- 3002807310
- 3010132111
- 3003595343
- 1424263
- 3015398319
- 2244478
- 3010220595
- 3010041693
- 3005180920
- 3005360851
- 3005551626
- 3006017180
- 2134285
- 3008102042
- 3004153896
- 3007200272
- 3002807090
- 3002807314
- 3009173317
- 1057425
- 3030412764
- 1531174
- 2011171
- 3018094310
- 3005323511
- 9614209
- 3042508254
- 1643817
- 9616671
- 3003761012
- 3002806603
- 3002808022
- 1058584
- 3008281151
- 3003998208
- 3015259876
- 2245304
- 3013176080
- 3009973336
- 3020162561
- 9681465
- 3006801265
- 3002807315
- 3010288357
- 3009973505
- 3011015572
- 3009882462
- 1833506
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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