The following data is part of a premarket notification filed by Emerge Medical, Inc. with the FDA for Emerge External Fixation System.
| Device ID | K140675 |
| 510k Number | K140675 |
| Device Name: | EMERGE EXTERNAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | EMERGE MEDICAL, INC. 720 S. COLORODO BLVD. SUITE 550-S Denver, CO 80246 |
| Contact | Michelle Potvin |
| Correspondent | Michelle Potvin EMERGE MEDICAL, INC. 720 S. COLORODO BLVD. SUITE 550-S Denver, CO 80246 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-18 |
| Decision Date | 2014-06-10 |
| Summary: | summary |