Cleared Traditional

LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999

K122637 · Stryker Spine · General & Plastic Surgery
Nov 2012
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K122637 is an FDA 510(k) clearance for the LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999, a Light, Surgical, Fiberoptic (Class II — Special Controls, product code FST), submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on November 1, 2012, 64 days after receiving the submission on August 29, 2012. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K122637 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2012
Decision Date November 01, 2012
Days to Decision 64 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FST — Light, Surgical, Fiberoptic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580

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