510(k) K925866
- Device
- CENATOR TOTAL HIP SYSTEM
- Applicant
- CORIN ORTHOPEDIC PRODUCTS
- 510(k) number
- K925866
- Product code
- JDI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-09-23
- Date received
- 1992-11-19
- 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
- JONATHAN S KAHAN
- Address
- C/O Hogan & Hartson 555 Thirteenth St., NW Washington DC US 20004 20004
FDA Registration Numbers#
- 3016851379
- 1000550978
- 1000200989
- 3007913880
- 3007200272
- 8010379
- 1221053
- 3011170410
- 3013450937
- 3003595343
- 1828288
- 3005551626
- 1220477
- 3035366890
- 3012329926
- 3013055499
- 3010097171
- 1018470
- 1833986
- 3008812251
- 3010132111
- 3004513872
- 1825034
- 3010314800
- 1836357
- 3002807295
- 3007366790
- 3006801265
- 3005718816
- 3002806603
- 3011015572
- 3001278222
- 3021008900
- 3020967480
- 3008102042
- 3010386387
- 3003639920
- 3010163695
- 3009871135
- 8044172
- 3042508254
- 3005061536
- 3009756327
- 3003998208
- 3008556682
- 3008395353
- 2011171
- 1423662
- 2133928
- 9681642
- 3015516266
- 1720929
- 9610612
- 3006128100
- 3009106092
- 1043653
- 3017397663
- 2245304
- 9681465
- 1450662
- 3009959868
- 1424263
- 1643817
- 1219655
- 3026771806
- 3000236920
- 3005360851
- 3009888740
- 3036756245
- 3004371426
- 2244478
- 3002807090
- 1531174
- 3011295718
- 3002807310
- 3005751028
- 3015259876
- 2528981
- 3005180920
- 3010468876
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#
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
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