The following data is part of a premarket notification filed by Ascension Orthopedics, Inc. with the FDA for Ascension Pyrosphere (pcs).
| Device ID | K042690 |
| 510k Number | K042690 |
| Device Name: | ASCENSION PYROSPHERE (PCS) |
| Classification | Prosthesis, Wrist, Carpal Trapezium |
| Applicant | ASCENSION ORTHOPEDICS, INC. 8200 CAMERON RD., SUITE C-140 Austin, TX 78754 -3832 |
| Contact | Peter Strzepa |
| Correspondent | Peter Strzepa ASCENSION ORTHOPEDICS, INC. 8200 CAMERON RD., SUITE C-140 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 | 2004-09-29 |
| Decision Date | 2004-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M269TRL435501 | K042690 | 000 |
| 00885556830765 | K042690 | 000 |
| 00885556830758 | K042690 | 000 |
| 00885556830741 | K042690 | 000 |
| 00885556830888 | K042690 | 000 |
| 00885556830871 | K042690 | 000 |
| 00885556830864 | K042690 | 000 |
| 00885556830857 | K042690 | 000 |
| 00885556830840 | K042690 | 000 |
| 00885556830772 | K042690 | 000 |
| 10381780114581 | K042690 | 000 |
| M269TRL435401 | K042690 | 000 |
| M269TRL435301 | K042690 | 000 |
| M269TRL435201 | K042690 | 000 |
| M269TRL435101 | K042690 | 000 |
| 10381780114628 | K042690 | 000 |
| 10381780114611 | K042690 | 000 |
| 10381780114604 | K042690 | 000 |
| 10381780114598 | K042690 | 000 |
| 00885556830789 | K042690 | 000 |