Name: Predicase
Price: 199 USD

K-number	K081106
Device name	PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139
Applicant	Smith & Nephew, Inc.
Product code	HRS
Device class	Class II
Decision date	Jun 18, 2008
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139

Everything you need for a 510(k) submission. Nothing you don't.