The following data is part of a premarket notification filed by Wright Medical with the FDA for Salvation External Fixation System.
| Device ID | K162033 |
| 510k Number | K162033 |
| Device Name: | SALVATION External Fixation System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | WRIGHT MEDICAL 1023 CHERRY ROAD Memphis, TN 38117 |
| Contact | Leslie Fitch |
| Correspondent | Leslie Fitch WRIGHT MEDICAL 1023 CHERRY ROAD Memphis, TN 38117 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-22 |
| Decision Date | 2017-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889797999311 | K162033 | 000 |
| 00889797054485 | K162033 | 000 |
| 00889797054492 | K162033 | 000 |
| 00889797054508 | K162033 | 000 |
| 00889797054546 | K162033 | 000 |
| 00889797054553 | K162033 | 000 |
| 00889797054560 | K162033 | 000 |
| 00889797054577 | K162033 | 000 |
| 00889797064323 | K162033 | 000 |
| 00889797064330 | K162033 | 000 |
| 00889797064347 | K162033 | 000 |
| 00889797999298 | K162033 | 000 |
| 00889797999304 | K162033 | 000 |
| 00889797054478 | K162033 | 000 |