The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Salvation External Fixation System.
| Device ID | K180832 |
| 510k Number | K180832 |
| Device Name: | SALVATION External Fixation System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Contact | Rachel Roberts |
| Correspondent | Rachel Roberts Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-30 |
| Decision Date | 2018-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420197955 | K180832 | 000 |
| 00840420194855 | K180832 | 000 |
| 00840420194862 | K180832 | 000 |
| 00840420194237 | K180832 | 000 |
| 00840420194879 | K180832 | 000 |
| 00840420194886 | K180832 | 000 |
| 00840420194893 | K180832 | 000 |
| 00840420197696 | K180832 | 000 |
| 00840420197702 | K180832 | 000 |
| 00840420197719 | K180832 | 000 |
| 00840420197726 | K180832 | 000 |
| 00840420197733 | K180832 | 000 |
| 00840420197740 | K180832 | 000 |
| 00840420197757 | K180832 | 000 |
| 00840420197849 | K180832 | 000 |
| 00840420197856 | K180832 | 000 |
| 00840420197870 | K180832 | 000 |
| 00840420197887 | K180832 | 000 |
| 00889797071895 | K180832 | 000 |