The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Optecure Bone Void Filler (0.5 Cc, 1cc, 2cc, 5cc, 10cc, And 20cc), Optecure + Ccc Bone Void Filler (1cc, 2cc, 5cc, 10cc,.
| Device ID | K121989 |
| 510k Number | K121989 |
| Device Name: | OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC, |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Gina Cassidy |
| Correspondent | Gina Cassidy EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-06 |
| Decision Date | 2012-11-27 |
| Summary: | summary |