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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: System 12
Classification Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Product Code: LPH
Device Class: 2
Regulation Number: 888.3358
Medical Specialty: Orthopedic
Registered Establishment Name: ALMARK TOOL & MANUFACTURING COMPANY, INC.
Registered Establishment Number: 3010041693
Owner/Operator: Almark Tool & Manufacturing Company, Inc.
Owner/Operator Number: 10043071
Establishment Operations: Contract Manufacturer
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