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 |