The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for Oxford Modular Shoulder Prosthesis, 192.xxx Catalogue Series.
| Device ID | K012377 |
| 510k Number | K012377 |
| Device Name: | OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Contact | Joel Batts |
| Correspondent | Joel Batts CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-26 |
| Decision Date | 2002-03-11 |
| Summary: | summary |