The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Prostep Mica Screw System.
| Device ID | K181377 |
| 510k Number | K181377 |
| Device Name: | PROSTEP MICA Screw System |
| Classification | Screw, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-24 |
| Decision Date | 2019-01-11 |