The following data is part of a premarket notification filed by Ascension Orthopedics, Inc. with the FDA for Ascension Pyrohemisphere, Models Phs-440-10, Phs-440-20, Phs-440-30, Phs-440-40, Phs-440-50.
| Device ID | K041451 |
| 510k Number | K041451 |
| Device Name: | ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 |
| 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 | 2004-06-01 |
| Decision Date | 2004-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M268PYROHEMIINSP1 | K041451 | 000 |
| 10381780114574 | K041451 | 000 |
| 10381780114567 | K041451 | 000 |
| 10381780114550 | K041451 | 000 |
| 10381780114543 | K041451 | 000 |
| 10381780114536 | K041451 | 000 |