The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Berlin External Fixator.
| Device ID | K954053 |
| 510k Number | K954053 |
| Device Name: | BERLIN EXTERNAL FIXATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Contact | J D Webb |
| Correspondent | J D Webb ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-29 |
| Decision Date | 1996-05-16 |
| Summary: | summary |