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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Duracon Knee System; Kinemax Knee System; PCA Acetabular System
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: HOWMEDICA INTERNATIONAL S. DE R.L.,
Registered Establishment Number: 9610726
Premarket Submission Number: K936292
Owner/Operator: STRYKER CORP.
Owner/Operator Number: 1811755
Establishment Operations: Manufacturer
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