The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Optecure; Optecure + Ccc.
| Device ID | K063685 |
| 510k Number | K063685 |
| Device Name: | OPTECURE; OPTECURE + CCC |
| Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Maritza Elias |
| Correspondent | Maritza Elias EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-12 |
| Decision Date | 2007-06-07 |