Home / 510(k) Clearances / K033242

510(k) K033242

KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) by Imaging Therapeutics, Inc. — Product Code HSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 2003
Date Received
October 7, 2003
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 Imaging Therapeutics, Inc.

  • K082402 — OSDX HIP BMD SYSTEM (October 16, 2008)

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