The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Evolve (r) Triad (tm) Plating System And Evolve (r) Triad (tm) Bone Screws.
| Device ID | K111432 |
| 510k Number | K111432 |
| Device Name: | EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS |
| Classification | Plate, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Angela Smith |
| Correspondent | Angela Smith WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-23 |
| Decision Date | 2011-08-19 |
| Summary: | summary |