The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Ceramic Spherical Cmc Implant (subject To Marketing Approval).
| Device ID | K960659 |
| 510k Number | K960659 |
| Device Name: | CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL) |
| Classification | Prosthesis, Wrist, Carpal Trapezium |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Cliff R Kline, Ii |
| Correspondent | Cliff R Kline, Ii WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | KYI |
| CFR Regulation Number | 888.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-16 |
| Decision Date | 1997-02-06 |
| Summary: | summary |