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510(k) K022779

OTI UNICONDULAR INTERPOSITIONAL SPACER by Osteoimplant Technology, Inc. — Product Code HSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2002
Date Received
August 22, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
Device Class
Class II
Regulation Number
888.3590
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)
  • 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)
  • K003199 — TRIAD II MODULAR TOTAL HIP SYSTEM (January 10, 2001)

Other clearances for product code HSH

  • K073233 — ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS (January 28, 2008)
  • K053094 — ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, (February 6, 2006)
  • K033242 — KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) (December 31, 2003)
  • K003269 — UNICONDYLAR INTERPOSITIONAL SPACER (January 4, 2001)