The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Prostep™ Tbi™ (tailors Bunion Implant) System.
Device ID | K190970 |
510k Number | K190970 |
Device Name: | PROSTEP™ TBI™ (Tailors Bunion Implant) System |
Classification | Screw, 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 | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-04-12 |
Decision Date | 2019-08-13 |