The following data is part of a premarket notification filed by Immedica, Inc. with the FDA for Transfx Intermediate External Fixation System,transfx Small External Fixation System, Transfx Mini External Fixation.
| Device ID | K990848 |
| 510k Number | K990848 |
| Device Name: | TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION |
| 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 |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-15 |
| Decision Date | 1999-05-17 |