Cleared Special

OSSTAPLE

K023203 · Biomedical Ent., Inc. · Orthopedic
Oct 2002
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K023203 is an FDA 510(k) clearance for the OSSTAPLE, 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 October 17, 2002, 22 days after receiving the submission on September 25, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K023203 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2002
Decision Date October 17, 2002
Days to Decision 22 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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