The following data is part of a premarket notification filed by Immedica, Inc. with the FDA for Transfx External Fixation System.
| Device ID | K984357 |
| 510k Number | K984357 |
| Device Name: | TRANSFX EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | IMMEDICA, INC. 100 PASSAIC AVE. Chatham, NJ 07928 -2848 |
| Contact | Roy Bogert |
| Correspondent | Roy Bogert IMMEDICA, INC. 100 PASSAIC AVE. Chatham, NJ 07928 -2848 |
| Product Code | LXT |
| Subsequent Product Code | JDW |
| Subsequent Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-07 |
| Decision Date | 1999-03-04 |