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510(k) K000817

OMEGA II MODULAR TOTAL HIP SYSTEM by Osteoimplant Technology, Inc. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2000
Date Received
March 13, 2000
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

Other clearances by Osteoimplant Technology, Inc.

  • K040685 — Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED (January 25, 2005)
  • K041443 — OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM (November 16, 2004)
  • K040225 — OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM (May 6, 2004)
  • K032729 — Z-SERIES MODULAR TOTAL HIP SYSTEM (December 3, 2003)
  • K030608 — OTI BONE CEMENT PLUG (June 12, 2003)
  • K022779 — OTI UNICONDULAR INTERPOSITIONAL SPACER (November 20, 2002)
  • K021822 — R120 MODULAR TOTAL HIP SYSTEM (July 23, 2002)
  • K012762 — MJS POSTERIOR STABILIZED KNEE SYSTEM (December 11, 2001)
  • K011774 — R120 MODULAR TOTAL HIP SYSTEM (September 5, 2001)
  • K003316 — OTI CERAMIC FEMORAL HEAD SYSTEM (January 19, 2001)

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