CORMET HIP RESURFACING SYSTEM
FDA premarket approval P050016/S005 · decided 2009-12-03
Approval details
- PMA number
- P050016
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CORMET HIP RESURFACING SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Applicant
- Corin USA
- Date received
- 2009-11-02
- Decision date
- 2009-12-03
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Raynham, MA
- Statement
- APPROVAL FOR LABELING CHANGES TO THE PACKAGE INSERT AND PATIENT BROCHURE TO INCLUDE TWO ADDITIONAL POTENTIAL ADVERSE EFFECTS, PSEUDOTUMOURS AND AVASCULAR LYMPHOCYTE DOMINATED VASCULITIS ASSOCIATED LESIONS (ALVAL) AS WELL AS AN ADDITIONAL PRECAUTION THAT THE SUBJECT DEVICE HAS NOT BEEN TESTED IN THE MAGNETIC RESONANCE (MR) ENVIRONMENT.
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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 |