Name: Predicase
Price: 199 USD

K-number	K020043
Device name	4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B
Applicant	Arthrex, Inc.
Product code	HWC
Device class	Class II
Decision date	Apr 2, 2002
Decision	Substantially Equivalent
Regulation	888.3040

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View the full FDA submission: accessdata.fda.gov

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4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B; 5.5 MM ARTHREX BIO-TENODESIS SCREW, MODELS AR-1555B

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