THE TAPER-FIT TOTAL HIP SYSTEM
FDA 510(k) clearance K992234 · decided 1999-11-10
Clearance details
- K-number
- K992234
- Device name
- THE TAPER-FIT TOTAL HIP SYSTEM
- Applicant
- Corin USA
- Decision
- Substantially Equivalent
- Date received
- 1999-07-02
- Decision date
- 1999-11-10
- Days to decision
- 131 days
- Clearance type
- Traditional
- Product code
- JDG
- Device class
- 2
- Regulation number
- 888.3360
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Tampa, FL, US
- Third-party review
- No
- Expedited review
- No
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| Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve (K212431) | Biomet, Inc. | 2022-02-07 |
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| Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (K173499) | Stryker Orthopaedics | 2018-03-19 |
| PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT (K001984) | Stelkast Company | 2000-09-27 |
| AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM (K962002) | Exactech, Inc. | 1996-08-08 |
| NEXLOCK FEMORAL STEM (K955171) | Nexmed, Inc. | 1996-02-09 |
| LUBINUS SP II HIP SYSTEM (K953653) | Turnkey Intergration USA, Inc. | 1995-11-06 |
| HIP FRACTURE STEM FENESTRATION PLUG (K953067) | Howmedica Corp. | 1995-08-21 |
| ORTHOMET TITANIUM HYBRID FEMORAL STEM (K945783) | Orthomet, Inc. | 1995-05-30 |
| PROFORM CEMENTED FEMORAL COMPONENT (K951083) | Stelkast Company | 1995-05-22 |
| INTEGRAL CO-CR FEMORAL COMPONENT (K942479) | Biomet, Inc. | 1994-09-20 |
| IMPACT CO-CR 1-PIECE FEMORAL COMPONENT (K942027) | Biomet, Inc. | 1994-09-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Cormet Hip Resurfacing System (P050016/S012) | Corin USA | 2020-07-17 |
| CORMET HIP RESURFACING SYSTEM (P050016/S011) | Corin USA | 2016-12-21 |
| CORMET HIP RESURFACING SYSTEM (P050016/S010) | Corin USA | 2014-04-03 |
| CORMET HIP RESURFACING SYSTEM (P050016/S009) | Corin USA | 2013-03-22 |
| CORMET HIP RESURFACING SYSTEM (P050016/S008) | Corin USA | 2011-11-10 |
| CORMET HIP RESURFACING SYSTEM (P050016/S007) | Corin USA | 2011-01-13 |
| CORMET HIP RESURFACING SYSTEM (P050016/S006) | Corin USA | 2009-12-31 |
| CORMET HIP RESURFACING SYSTEM (P050016/S005) | Corin USA | 2009-12-03 |