Cleared Special

SURGICAL DYNAMICS MENISCAL STAPLE

K013890 · United States Surgical, A Division of Tyco Healthc · Orthopedic
Dec 2001
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K013890 is an FDA 510(k) clearance for the SURGICAL DYNAMICS MENISCAL STAPLE, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on December 11, 2001, 18 days after receiving the submission on November 23, 2001. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K013890 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2001
Decision Date December 11, 2001
Days to Decision 18 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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