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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Simplex Bone Cement
Classification Name: BONE CEMENT
Product Code: LOD
Device Class: 2
Regulation Number: 888.3027
Medical Specialty: Orthopedic
Registered Establishment Name: HOWMEDICA INTERNATIONAL S. DE R.L.,
Registered Establishment Number: 9610726
Premarket Submission Number: K014199
Owner/Operator: STRYKER CORP.
Owner/Operator Number: 1811755
Establishment Operations: Manufacturer
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