The following data is part of a premarket notification filed by Avanta Orthopaedics, Inc. with the FDA for Modification To Radial Head Implant.
| Device ID | K023604 |
| 510k Number | K023604 |
| Device Name: | MODIFICATION TO RADIAL HEAD IMPLANT |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Applicant | AVANTA ORTHOPAEDICS, INC. 9369 CARROLL PARK DRIVE, STE.A San Diego, CA 92121 |
| Contact | Louise Focht |
| Correspondent | Louise Focht AVANTA ORTHOPAEDICS, INC. 9369 CARROLL PARK DRIVE, STE.A San Diego, CA 92121 |
| Product Code | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-28 |
| Decision Date | 2002-11-27 |
| Summary: | summary |