Name: Predicase
Price: 199 USD

K-number	K191641
Device name	AFFINITY Variable Angle Distal Radius System, AFFINITY Variable Angle Distal Radius Plates, AFFINITY Variable Angle Distal Radius Screws
Applicant	Industrias Medicas Sampedro S.A.S
Product code	HRS
Device class	Class II
Decision date	Sep 16, 2019
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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AFFINITY  Variable Angle Distal Radius System, AFFINITY  Variable Angle Distal Radius Plates, AFFINITY  Variable Angle Distal Radius Screws

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AFFINITY Variable Angle Distal Radius System, AFFINITY Variable Angle Distal Radius Plates, AFFINITY Variable Angle Distal Radius Screws