Cleared Traditional

K051611 - MBARESORB IMPLANT
(FDA 510(k) Clearance)

K051611 · Kinetikos Medical, Inc. · Orthopedic

Sep 2005

Decision

81d

Days

Class 2

Risk

K051611 is an FDA 510(k) clearance for the MBARESORB IMPLANT. This device is classified as a Screw, Fixation, Bone (Class II — Special Controls, product code HWC).

Submitted by Kinetikos Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on September 6, 2005, 81 days after receiving the submission on June 17, 2005.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K051611 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2005
Decision Date	September 06, 2005
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF