Cleared Traditional

HAMMERLOCK

K091951 · Biomedical Ent., Inc. · Orthopedic
Feb 2010
Decision
233d
Days
Class 2
Risk

About This 510(k) Submission

K091951 is an FDA 510(k) clearance for the HAMMERLOCK, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by Biomedical Ent., Inc. (San Antonio, US). The FDA issued a Cleared decision on February 19, 2010, 233 days after receiving the submission on July 1, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K091951 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2009
Decision Date February 19, 2010
Days to Decision 233 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTY — Pin, Fixation, Smooth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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