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510(k) Number

K061668 ↗

FDA product code

MBP

Device class

Class II

Regulation

21 CFR Part 888.3045

Advisory committee

Orthopedic

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

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)).

• GRAFTON PLUS DBM PASTE by Osteotech, Inc.
• VIVORTE BVF by Vivorte, Inc
• CAP PLUS, EQUIVABONE, CAP/DBM by Etex Corp.
• GRAFTON DBM by Osteotech, Inc.
• DBX Strip by Musculoskeletal Transplant Foundation
• AFT Allograft Filler Tube by Musculoskeletal Transplant Foundation
• PliaFX Flo by LIFENET HEALTH
• Vivorte Trabexus EB by Vivorte, Inc
• BIOSET XC by Regeneration Technologies, Inc.
• PROGENIX DBM PUTTY AND PASTE by MEDTRONIC SOFAMOR DANEK, 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. →