The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Afghan External Fixator.
| Device ID | K092002 |
| 510k Number | K092002 |
| Device Name: | AFGHAN EXTERNAL FIXATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Laura Sejnowski |
| Correspondent | Laura Sejnowski SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-02 |
| Decision Date | 2009-12-10 |
| Summary: | summary |