The following data is part of a premarket notification filed by Ascension Orthopedics, Inc. with the FDA for Ascension, Models Cmc-400,13,cmc-400-20,cmc-400-30,cmc-400-40.
| Device ID | K061451 |
| 510k Number | K061451 |
| Device Name: | ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 |
| Classification | Prosthesis, Wrist, Carpal Trapezium |
| Applicant | ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin, TX 78754 -3832 |
| Contact | Glen Neally |
| Correspondent | Glen Neally ASCENSION ORTHOPEDICS, INC. 8700 CAMERON RD., STE. 100 Austin, TX 78754 -3832 |
| Product Code | KYI |
| CFR Regulation Number | 888.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-25 |
| Decision Date | 2006-08-11 |
| Summary: | summary |