The following data is part of a premarket notification filed by Avanta Orthopaedics, Inc. with the FDA for Avanta Orthopaedics Tendon Spacer.
| Device ID | K964359 |
| 510k Number | K964359 |
| Device Name: | AVANTA ORTHOPAEDICS TENDON SPACER |
| Classification | Prosthesis, Tendon, Passive |
| Applicant | AVANTA ORTHOPAEDICS, INC. 9369 CARROLL PARK DRIVE, STE.A San Diego, CA 92121 |
| Contact | Louise M Focht |
| Correspondent | Louise M Focht AVANTA ORTHOPAEDICS, INC. 9369 CARROLL PARK DRIVE, STE.A San Diego, CA 92121 |
| Product Code | HXA |
| CFR Regulation Number | 888.3025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-01 |
| Decision Date | 1997-03-25 |
| Summary: | summary |