The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Prostep Tbc Implant System.
| Device ID | K183620 |
| 510k Number | K183620 |
| Device Name: | PROSTEP TBC Implant System |
| Classification | Plate, Fixation, Bone |
| Applicant | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
| Contact | Michael Mullins |
| Correspondent | Michael Mullins 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 | 2018-12-26 |
| Decision Date | 2019-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889797073158 | K183620 | 000 |
| 00889797073141 | K183620 | 000 |
| 00889797073134 | K183620 | 000 |
| 00889797073127 | K183620 | 000 |
| 00889797073110 | K183620 | 000 |
| 00889797073103 | K183620 | 000 |