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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Smartset (bone cement)
Classification Name: BONE CEMENT
Product Code: LOD
Device Class: 2
Regulation Number: 888.3027
Medical Specialty: Orthopedic
Registered Establishment Name: DEPUY CMW
Registered Establishment Number: 9610921
Premarket Submission Number: K081155
Owner/Operator: DePuy Synthes, Inc.
Owner/Operator Number: 1818910
Establishment Operations: Manufacturer; Specification Developer
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