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510(k) K922421

KINAMED ATH-POROUS AND ATH-POROUS LONG TOTAL HIP by Kinamed, Inc. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1992
Date Received
May 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

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  • K010101 — GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM (May 17, 2001)
  • K003347 — ORTHOPILOT (February 23, 2001)

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