The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Subtalar Spacer System (sts).
| Device ID | K150213 |
| 510k Number | K150213 |
| Device Name: | Subtalar Spacer System (STS) |
| Classification | Screw, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 1023 Cherry Road Memphis, TN 38117 |
| Contact | Tara Conrad |
| Correspondent | Tara Conrad WRIGHT MEDICAL TECHNOLOGY, INC. 1023 Cherry Road Memphis, TN 38117 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-30 |
| Decision Date | 2015-05-08 |
| Summary: | summary |