The following data is part of a premarket notification filed by Avanta Orthopaedics, Inc. with the FDA for External Fixator.
| Device ID | K974911 |
| 510k Number | K974911 |
| Device Name: | EXTERNAL FIXATOR |
| Classification | Pin, Fixation, Threaded |
| 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 | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-31 |
| Decision Date | 1998-03-16 |
| Summary: | summary |