CORMET HIP RESURFACING SYSTEM
FDA premarket approval P050016/S011 · decided 2016-12-21
Approval details
- PMA number
- P050016
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- CORMET HIP RESURFACING SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Applicant
- Corin USA
- Date received
- 2016-07-06
- Decision date
- 2016-12-21
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Raynham, MA
- Statement
- Approval for an update to the device labeling (i.e., package insert, surgical technique, and patient labeling) to include a summary of the results of the completed post-approval study (PAS).
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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 |