Cleared Traditional

S-Wire

K152662 · Spinal Resources, Inc. · Orthopedic
Mar 2016
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K152662 is an FDA 510(k) clearance for the S-Wire, a Pin, Fixation, Smooth (Class II — Special Controls, product code HTY), submitted by Spinal Resources, Inc. (Indian Harbour Beach, US). The FDA issued a Cleared decision on March 9, 2016, 174 days after receiving the submission on September 17, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K152662 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2015
Decision Date March 09, 2016
Days to Decision 174 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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