The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Jet-x Bar Clamps And Pin Clamps-non-magnetic/mr Safe.
| Device ID | K042312 |
| 510k Number | K042312 |
| Device Name: | JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/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 | 2004-08-26 |
| Decision Date | 2004-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010516763 | K042312 | 000 |