The following data is part of a premarket notification filed by Biodynamic Technologies, Inc. with the FDA for Ez-fix Compression Hip/supracondylar Screw (chs) System.
| Device ID | K962846 |
| 510k Number | K962846 |
| Device Name: | EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | BIODYNAMIC TECHNOLOGIES, INC. 1425 EAST NEWPORT CENTER DR. Deerfield Beach, FL 33442 |
| Contact | Danny Hodgeman |
| Correspondent | Danny Hodgeman BIODYNAMIC TECHNOLOGIES, INC. 1425 EAST NEWPORT CENTER DR. Deerfield Beach, FL 33442 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-22 |
| Decision Date | 1996-10-23 |
| Summary: | summary |