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510(k) K924050

TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT by Orthomet, Inc. — Product Code KWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1993
Date Received
August 5, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

Other clearances by Orthomet, Inc.

  • K936310 — ORTHOMET HMC FEMORAL STEM COMPONENT (June 7, 1995)
  • K945783 — ORTHOMET TITANIUM HYBRID FEMORAL STEM (May 30, 1995)
  • K943873 — ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY (April 26, 1995)
  • K944752 — ORTHOMET RESURFACING FEMORAL COMPONENT (December 28, 1994)
  • K930771 — PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM (November 30, 1994)
  • K926334 — AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER (October 18, 1994)
  • K931678 — ORTHOMET LHMC FEMORAL STEM (October 14, 1994)
  • K932677 — AXIOM TOTAL KNEE SYSTEM (October 14, 1994)
  • K931333 — ORTHOMET ACETABULAR CUP SYSTEM (October 14, 1994)
  • K925536 — HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM (January 7, 1994)

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