SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY— 510(k) K102544

Name: FDA 510(k) clearance K102544
Creator: U.S. Food and Drug Administration
Published: 2011-01-05

Substantially Equivalent

Smith & Nephew Inc., Endoscopy Div.

FDA 510(k) clearance K102544 for SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY, Substantially Equivalent on 2011-01-05. Applicant: Smith & Nephew Inc., Endoscopy Div.. Device class: 2.

Clearance details

Applicant: Smith & Nephew Inc., Endoscopy Div.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2010-09-03
Decision date: 2011-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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