OPTECURE - Optecure

510(k) Number

K063685 ↗

FDA product code

MBP

Models / Variants

Optecure

Optecure + Ccc

Device class

Class II

Regulation

21 CFR Part 888.3045

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)).

• SYGNAL DBM by Musculoskeletal Transplant Foundation
• Vivorte Trabexus EB by Vivorte, Inc
• BIOSET XC by Regeneration Technologies, Inc.
• PROGENIX DBM PUTTY AND PASTE by MEDTRONIC SOFAMOR DANEK, INC.
• DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE by Musculoskeletal Transplant Foundation
• ACCELL TBM-R by ISOTIS ORTHOBIOLOGICS, INC
• DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY by Orthocon, Inc.
• ACCELL EVO3 (FORMERLY ACCELL A2I) by Integra Lifesciences Corp.
• CLEARED UNDER GRAFTON II EDBM by MEDTRONIC SOFAMOR DANEK, INC.
• ACCELL EVO3C by ISOTIS ORTHOBIOLOGICS, INC

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

• Vantage® Total Ankle

  Class III

  CE/MDR MDR 777490 Active Valid to Sep 2031

See all devices from Exactech, Inc. →