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510(k) K960685

ORTHODOC PREOPERATIVE PLANNER MODEL 500 by Integrated Surgical Systems, Inc. — Product Code HWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1997
Date Received
February 20, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Template
Device Class
Class I
Regulation Number
888.4800
Review Panel
OR
Submission Type

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Other clearances for product code HWT

  • K974406 — ORTHOPLAN (February 18, 1998)
  • K894228 — KRONNER SPHERICAL CUTTERS (July 23, 1990)
  • K870843 — SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA (May 27, 1987)
  • K871323 — ARTHROSCOPIC MENISCAL SUTURE SYSTEM (May 1, 1987)
  • K830360 — 3M OSTEOTOMY GUIDE (March 1, 1983)
  • K811205 — MOLDED POLYSULFONE TRIAL PROSTHESIS (May 21, 1981)
  • K781091 — KNEE INSTRUMENTATION, CONDYLAR (July 17, 1978)
  • K771709 — WORRELL TRIAL PATELLA (October 6, 1977)
  • K771710 — WORRELL PATELLA TEMPLATE (October 6, 1977)