The following data is part of a premarket notification filed by Corin Usa with the FDA for Corin Optimized Positioning System (ops) Femoral.
| Device ID | K181061 |
| 510k Number | K181061 |
| Device Name: | Corin Optimized Positioning System (OPS) Femoral |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Corin USA 12750 Citrus Park Lane, Suite 120 Tampa, FL 33625 |
| Contact | Lucinda Gerber |
| Correspondent | Crissy Tomarelli Corin (Australia) 17 Bridge Street Sydney, AU 2073 |
| Product Code | LZO |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | MEH |
| Subsequent Product Code | PBF |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-23 |
| Decision Date | 2018-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09351327000084 | K181061 | 000 |