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510(k) K073233

ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS by Advanced Bio-Surfaces, Inc. — Product Code HSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2008
Date Received
November 15, 2007
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 Advanced Bio-Surfaces, Inc.

  • K053094 — ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, (February 6, 2006)

Other clearances for product code HSH

  • 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)
  • K022779 — OTI UNICONDULAR INTERPOSITIONAL SPACER (November 20, 2002)
  • K003269 — UNICONDYLAR INTERPOSITIONAL SPACER (January 4, 2001)