The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Hex-fix Field Fixator.
| Device ID | K953397 |
| 510k Number | K953397 |
| Device Name: | HEX-FIX FIELD FIXATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
| Contact | Marc Wheetley |
| Correspondent | Marc Wheetley SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-20 |
| Decision Date | 1995-10-31 |