Cleared Traditional

OSTEOTEC SILICONE FINGER IMPLANT

K140453 · Osteotec, Ltd. · Orthopedic

Apr 2015

Decision

417d

Days

Class 2

Risk

About This 510(k) Submission

K140453 is an FDA 510(k) clearance for the OSTEOTEC SILICONE FINGER IMPLANT, a Prosthesis, Finger, Constrained, Polymer (Class II — Special Controls, product code KYJ), submitted by Osteotec, Ltd. (Christchurch, Dorset, GB). The FDA issued a Cleared decision on April 17, 2015, 417 days after receiving the submission on February 24, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3230.

Submission Details

510(k) Number	K140453 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 2014
Decision Date	April 17, 2015
Days to Decision	417 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF