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 | K150004 |
| 510k Number | K150004 |
| 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 | Leslie Fitch |
| Correspondent | Leslie Fitch WRIGHT MEDICAL TECHNOLOGY, INC. 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 | 2015-01-02 |
| Decision Date | 2015-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889797056076 | K150004 | 000 |
| 00840420160577 | K150004 | 000 |
| 00840420160584 | K150004 | 000 |
| 00840420160591 | K150004 | 000 |
| 00840420160607 | K150004 | 000 |
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| 00840420160560 | K150004 | 000 |
| 00840420160553 | K150004 | 000 |
| 00840420160546 | K150004 | 000 |
| 00889797060639 | K150004 | 000 |
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| 00840420160836 | K150004 | 000 |
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| 00840420160737 | K150004 | 000 |
| 00840420160744 | K150004 | 000 |
| 00840420185754 | K150004 | 000 |