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 | K171852 |
| 510k Number | K171852 |
| Device Name: | DARCO Locking Bone Plate System |
| Classification | Plate, Fixation, Bone |
| Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Contact | Val Myles |
| Correspondent | Val Myles Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-21 |
| Decision Date | 2017-09-21 |
| Summary: | summary |