Cleared Traditional

K051386 - MASTERGRAFT PUTTY BONE VOID FILLER (FDA 510(k) Clearance)

K051386 · Medtronic Vascular · Orthopedic device

Dec 2005

Decision

203d

Days

Class 2

Risk

K051386 is an FDA 510(k) clearance for the MASTERGRAFT PUTTY BONE VOID FILLER. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Medtronic Vascular (Memphis, US). The FDA issued a Cleared decision on December 16, 2005, 203 days after receiving the submission on May 27, 2005.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number	K051386 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 27, 2005
Decision Date	December 16, 2005
Days to Decision	203 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF