The following data is part of a premarket notification filed by Ascension Orthopedics, Inc. with the FDA for Ascension Pyrosphere Cmc/tmt.
| Device ID | K060560 |
| 510k Number | K060560 |
| Device Name: | ASCENSION PYROSPHERE CMC/TMT |
| Classification | Prosthesis, Toe, Hemi-, Phalangeal |
| 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 | KWD |
| CFR Regulation Number | 888.3730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-02 |
| Decision Date | 2006-05-05 |
| Summary: | summary |