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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: FASTIN RC ANCHOR
Classification Name: SCREW, FIXATION, BONE
Product Code: HWC
Device Class: 2
Regulation Number: 888.3040
Medical Specialty: Orthopedic
Registered Establishment Name: DePuy Mitek, Inc.
Registered Establishment Number: 1221934
Premarket Submission Number: K041075
Owner/Operator: DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
Owner/Operator Number: 1221934
Establishment Operations: Specification Developer
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