The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Rx-fix Mini Rail External Fixator.
| Device ID | K150640 |
| 510k Number | K150640 |
| Device Name: | RX-FIX Mini Rail External Fixator |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 1023 Cherry Road Memphis, TN 38111 |
| Contact | Leslie Fitch |
| Correspondent | Leslie Fitch WRIGHT MEDICAL TECHNOLOGY, INC. 1023 Cherry Road Memphis, TN 38111 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-11 |
| Decision Date | 2015-12-01 |
| Summary: | summary |