The following data is part of a premarket notification filed by Trend Medical, Inc. with the FDA for Trauma-fix External Fixator.
| Device ID | K971272 |
| 510k Number | K971272 |
| Device Name: | TRAUMA-FIX EXTERNAL FIXATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Applicant | TREND MEDICAL, INC. 1000 BURNETT AVE., SUITE 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf TREND MEDICAL, INC. 1000 BURNETT AVE., SUITE 450 Concord, CA 94520 |
| Product Code | KTW |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-04 |
| Decision Date | 1997-06-05 |
| Summary: | summary |