The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Jet-x Bar System Clamps And Posts Reprocessing.
| Device ID | K100795 |
| 510k Number | K100795 |
| Device Name: | JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Shereen Myers |
| Correspondent | Shereen Myers 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 | 2010-03-22 |
| Decision Date | 2010-09-02 |
| Summary: | summary |