The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Questus Polyester Suture Soft Tissue Anchor System.
| Device ID | K963200 |
| 510k Number | K963200 |
| Device Name: | QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Cristie Manuel |
| Correspondent | Cristie Manuel WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-15 |
| Decision Date | 1996-10-02 |
| Summary: | summary |