The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Equinoxe Cuff Tear Arthroplasty (cta) Head.
| Device ID | K110706 |
| 510k Number | K110706 |
| Device Name: | EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Graham L Cuthbert |
| Correspondent | Graham L Cuthbert EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-14 |
| Decision Date | 2011-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862171351 | K110706 | 000 |
| 10885862171344 | K110706 | 000 |