The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Darco Locking Bone Plate System.
| Device ID | K150520 |
| 510k Number | K150520 |
| Device Name: | DARCO Locking Bone Plate System |
| Classification | Plate, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 1023 Cherry Road Memphis, TN 38117 |
| Contact | Jeanine Redden |
| Correspondent | Jeanine Redden WRIGHT MEDICAL TECHNOLOGY, INC. 1023 Cherry Road Memphis, TN 38117 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-02 |
| Decision Date | 2015-04-29 |
| Summary: | summary |