Cleared Special

OSSTAPLE CHILL

K102107 · Biomedical Ent., Inc. · Orthopedic
Sep 2010
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K102107 is an FDA 510(k) clearance for the OSSTAPLE CHILL, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Biomedical Ent., Inc. (San Antonio, US). The FDA issued a Cleared decision on September 3, 2010, 38 days after receiving the submission on July 27, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K102107 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2010
Decision Date September 03, 2010
Days to Decision 38 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDR — Staple, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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