The following data is part of a premarket notification filed by Dynasplint Systems, Inc. with the FDA for External Fixation.
| Device ID | K904973 |
| 510k Number | K904973 |
| Device Name: | EXTERNAL FIXATION |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | DYNASPLINT SYSTEMS, INC. 6655 AMBERTON DRIVE SUITE A Baltimore, MD 21227 |
| Contact | George R Hepburn |
| Correspondent | George R Hepburn DYNASPLINT SYSTEMS, INC. 6655 AMBERTON DRIVE SUITE A Baltimore, MD 21227 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-29 |
| Decision Date | 1991-02-21 |