The following data is part of a premarket notification filed by Ascension Orthopedic with the FDA for Titan Modular Total Shoulder System.
| Device ID | K112438 |
| 510k Number | K112438 |
| Device Name: | TITAN MODULAR TOTAL SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | ASCENSION ORTHOPEDIC 8700 CAMERON RD., STE. 100 Austin, TX 78754 |
| Contact | Susan Walton |
| Correspondent | Susan Walton ASCENSION ORTHOPEDIC 8700 CAMERON RD., STE. 100 Austin, TX 78754 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-24 |
| Decision Date | 2012-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556837702 | K112438 | 000 |
| 00885556837696 | K112438 | 000 |
| 00885556837689 | K112438 | 000 |
| 00885556837672 | K112438 | 000 |
| 00885556837665 | K112438 | 000 |
| 00885556837658 | K112438 | 000 |