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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Plasmafit Pro Acetabular Cup System and Vitelene Insert
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: AESCULAP AG
Registered Establishment Number: 9610612
Owner/Operator: Aesculap AG
Owner/Operator Number: 8010193
Establishment Operations: Manufacturer; Complaint File Establishment
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