The following data is part of a premarket notification filed by Ascension Orthopedics, Inc. with the FDA for Ascension Modular Total Shoulder System.
| Device ID | K100448 |
| 510k Number | K100448 |
| Device Name: | ASCENSION MODULAR TOTAL SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin, TX 78754 -3832 |
| Contact | Stanley J Harris |
| Correspondent | Stanley J Harris ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin, TX 78754 -3832 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-17 |
| Decision Date | 2010-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556862148 | K100448 | 000 |
| 00885556860380 | K100448 | 000 |
| 00885556860373 | K100448 | 000 |
| 00885556860366 | K100448 | 000 |
| 00885556860359 | K100448 | 000 |
| 00885556860342 | K100448 | 000 |
| 00885556859537 | K100448 | 000 |
| 00885556837757 | K100448 | 000 |
| 00885556837740 | K100448 | 000 |
| 00885556837733 | K100448 | 000 |
| 00885556837726 | K100448 | 000 |
| 00885556860397 | K100448 | 000 |
| 00885556860403 | K100448 | 000 |
| 00885556860410 | K100448 | 000 |
| 00885556862131 | K100448 | 000 |
| 00885556862124 | K100448 | 000 |
| 00885556862117 | K100448 | 000 |
| 00885556862100 | K100448 | 000 |
| 00885556862094 | K100448 | 000 |
| 00885556862087 | K100448 | 000 |
| 00885556862070 | K100448 | 000 |
| 00885556862063 | K100448 | 000 |
| 00885556862056 | K100448 | 000 |
| 00885556862049 | K100448 | 000 |
| 00885556837719 | K100448 | 000 |