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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K934729
Device Name UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED
Applicant
IMPLANTOLOGY CORP.
11 OAK LN.
PINE BROOK,  NJ  07058
Applicant Contact MARK R FORTE
Correspondent
IMPLANTOLOGY CORP.
11 OAK LN.
PINE BROOK,  NJ  07058
Correspondent Contact MARK R FORTE
Regulation Number888.3353
Classification Product Code
MEH  
Date Received09/29/1993
Decision Date 07/22/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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