The following data is part of a premarket notification filed by Biodynamic Technologies, Inc. with the FDA for Ez Fix.
| Device ID | K954838 | 
| 510k Number | K954838 | 
| Device Name: | EZ FIX | 
| Classification | Component, Traction, Invasive | 
| Applicant | BIODYNAMIC TECHNOLOGIES, INC. 1425 EAST NEWPORT CENTER DR. Deerfield Beach, FL 33442 | 
| Contact | Danny Hoddgeman | 
| Correspondent | Danny Hoddgeman BIODYNAMIC TECHNOLOGIES, INC. 1425 EAST NEWPORT CENTER DR. Deerfield Beach, FL 33442 | 
| Product Code | JEC | 
| CFR Regulation Number | 888.3040 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1995-10-20 | 
| Decision Date | 1996-01-24 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  EZ FIX  85899738  not registered Dead/Abandoned | Hamilton, Mark 2013-04-10 | 
|  EZ FIX  77170260  not registered Dead/Abandoned | World Wide Stationery Manufacturing Company Limited 2007-05-01 |