OPTECURE
Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
EXACTECH, INC.
The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Optecure.
Pre-market Notification Details
| Device ID | K050806 |
| 510k Number | K050806 |
| Device Name: | OPTECURE |
| Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Rebecca S Roberts |
| Correspondent | Rebecca S Roberts 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 | 2005-03-30 |
| Decision Date | 2006-02-08 |
| Summary: | summary |
Trademark Results [OPTECURE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTECURE 76607425 3174560 Live/Registered |
Exactech, Inc. 2004-08-13 |
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