Cleared Traditional

K200507 - PRO-DENSE LoVisc Bone Graft Substitute (FDA 510(k) Clearance)

K200507 · Wrightmedicaltechnologyinc · Orthopedic device

Oct 2020

Decision

233d

Days

Class 2

Risk

K200507 is an FDA 510(k) clearance for the PRO-DENSE LoVisc Bone Graft Substitute. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on October 21, 2020, 233 days after receiving the submission on March 2, 2020.

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

Submission Details

510(k) Number	K200507 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 02, 2020
Decision Date	October 21, 2020
Days to Decision	233 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF