The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Jet-x Bar System Clamps, Bars And Posts-mr Safe.
| Device ID | K072212 |
| 510k Number | K072212 |
| Device Name: | JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | David Henley |
| Correspondent | David Henley SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-09 |
| Decision Date | 2008-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556012949 | K072212 | 000 |
| 03596010607805 | K072212 | 000 |
| 03596010607812 | K072212 | 000 |
| 03596010607829 | K072212 | 000 |
| 03596010607836 | K072212 | 000 |
| 03596010607867 | K072212 | 000 |
| 03596010607874 | K072212 | 000 |
| 03596010607881 | K072212 | 000 |
| 03596010607898 | K072212 | 000 |
| 03596010495976 | K072212 | 000 |
| 03596010495983 | K072212 | 000 |
| 03596010495990 | K072212 | 000 |
| 03596010607683 | K072212 | 000 |
| 03596010607690 | K072212 | 000 |
| 03596010607904 | K072212 | 000 |
| 03596010607911 | K072212 | 000 |
| 03596010607928 | K072212 | 000 |
| 03596010495969 | K072212 | 000 |