Cleared Special

K031817 - CELLPLEX TCP SYNTHETIC CANCELLOUS BONE (FDA 510(k) Clearance)

K031817 · Wrightmedicaltechnologyinc · Orthopedic device

Jul 2003

Decision

35d

Days

Class 2

Risk

K031817 is an FDA 510(k) clearance for the CELLPLEX TCP SYNTHETIC CANCELLOUS BONE. This device is classified as a Filler, Bone Void, Calcium Compound (Class II - Special Controls, product code MQV).

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on July 17, 2003, 35 days after receiving the submission on June 12, 2003.

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

Submission Details

510(k) Number	K031817 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 12, 2003
Decision Date	July 17, 2003
Days to Decision	35 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF