The following data is part of a premarket notification filed by Ascension Orthopedics, Inc. with the FDA for Ascension Modular Radial Head.
| Device ID | K032686 |
| 510k Number | K032686 |
| Device Name: | ASCENSION MODULAR RADIAL HEAD |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| 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 | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-29 |
| Decision Date | 2003-10-22 |
| Summary: | summary |