510(k) K952731
- Device
- TOWNLEY ALL POLY ACETABULAR CUP
- Applicant
- BIOLOGICALLY ORIENTED PROSTHESES
- 510(k) number
- K952731
- Product code
- JDI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-12-28
- Date received
- 1995-06-15
- 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
- CHERYL L WARSINSKE
- Address
- 17 Seventeenth St. Port Huron MI US 48060 48060
FDA Registration Numbers#
- 1833920
- 9681642
- 3003998208
- 3005061536
- 1030489
- 3002808022
- 3004513872
- 3009173317
- 2648920
- 1644408
- 3010287737
- 9616671
- 1047843
- 9610726
- 3010041693
- 3010846112
- 3035366890
- 1226544
- 3026771806
- 3013302242
- 3003541440
- 9613369
- 3002807314
- 3008868758
- 3007200272
- 3009973336
- 3014644608
- 3003595343
- 3005323511
- 3004371426
- 3007923096
- 1643264
- 3010386387
- 1649518
- 1827096
- 2134285
- 1721676
- 1221053
- 3014252644
- 3010468876
- 1818910
- 3009546990
- 3038503932
- 1833506
- 3015167917
- 2246552
- 9681465
- 1000200989
- 3006395932
- 3007366790
- 1828288
- 3022142628
- 1529009
- 3010178296
- 2133928
- 3042508254
- 3020162561
- 3036773273
- 1018470
- 3012523063
- 1649390
- 1531174
- 3002806535
- 3002807315
- 3002807295
- 3020155054
- 1000550978
- 3004748528
- 1835251
- 3005551626
- 3005718816
- 3013014058
- 1423662
- 2528981
- 1043653
- 3043543260
- 3018052045
- 2011171
- 3012319330
- 3009475821
Source Documents#
Other 510(k) Records For Product Code JDI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K203090 | ELEOS Limb Salvage System featuring BIOGRIP | Onkos Surgical | 2020-12-11 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases