The following data is part of a premarket notification filed by Ascension Orthopedics, Inc. with the FDA for Ascension Muh.
| Device ID | K052137 |
| 510k Number | K052137 |
| Device Name: | ASCENSION MUH |
| Classification | Prosthesis, Wrist, Hemi-, Ulnar |
| 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 | KXE |
| CFR Regulation Number | 888.3810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-05 |
| Decision Date | 2005-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556826300 | K052137 | 000 |
| 00885556826201 | K052137 | 000 |
| 00885556826218 | K052137 | 000 |
| 00885556826225 | K052137 | 000 |
| 00885556826232 | K052137 | 000 |
| 00885556826249 | K052137 | 000 |
| 00885556826256 | K052137 | 000 |
| 00885556826263 | K052137 | 000 |
| 00885556826270 | K052137 | 000 |
| 00885556826287 | K052137 | 000 |
| 00885556826294 | K052137 | 000 |
| 00885556826195 | K052137 | 000 |