CORMET HIP RESUFACING SYSTEM
FDA premarket approval P050016/S004 · decided 2008-11-04
Approval details
- PMA number
- P050016
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- CORMET HIP RESUFACING SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Applicant
- Corin USA
- Date received
- 2008-09-29
- Decision date
- 2008-11-04
- Days to decision
- 36 days
- Decision code
- APPR
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Raynham, MA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| OMNIVision system (K203751) | Corin USA | 2021-04-12 |
| Optimized Positioning System (OPS) Insight (K202805) | Corin USA | 2020-11-20 |
| Corin Optimized Positioning System (OPS) Femoral (K193545) | Corin USA | 2020-08-04 |
| Optimized Positioning System (OPS) ReView (K193042) | Corin USA | 2020-06-26 |
| Optimized Positioning System (OPS) Insight (K192656) | Corin USA | 2020-05-01 |
| LARS AC Band Device (K190143) | Corin USA | 2019-11-04 |
| Corin Optimized Position System Functional Hip Analysis (OPS FHA) (K190834) | Corin USA | 2019-07-22 |
| Corin Optimized Positioning System (OPS) Plan (K183038) | Corin USA | 2018-11-26 |