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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, ankle, semi-constrained, cemented, metal/polymer
510(k) Number K100886
Device Name INBONE II TOTAL ANKLE REPLACEMENT
Applicant
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON,  TN  38002
Applicant Contact KELSEY LEE
Correspondent
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE RD.
ARLINGTON,  TN  38002
Correspondent Contact KELSEY LEE
Regulation Number888.3110
Classification Product Code
HSN  
Date Received03/30/2010
Decision Date 08/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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