The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Optetrak Proximal Tibial Spacer.
| Device ID | K071738 |
| 510k Number | K071738 |
| Device Name: | EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32608 |
| Contact | Amnon Talmor |
| Correspondent | Amnon Talmor EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32608 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-26 |
| Decision Date | 2007-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862186775 | K071738 | 000 |
| 10885862186782 | K071738 | 000 |