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510(k) K974406

ORTHOPLAN by Ortho-Graphics, Inc. — Product Code HWT

K974406 is an FDA 510(k) premarket notification submitted by Ortho-Graphics, Inc. for the device "ORTHOPLAN". The FDA issued a decision of Substantially Equivalent on February 18, 1998. The device falls under product code HWT (Template), a Class I device regulated under 21 CFR 888.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1998
Date Received
November 21, 1997
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

Other clearances for product code HWT

  • K960685 — ORTHODOC PREOPERATIVE PLANNER MODEL 500 (January 17, 1997)
  • 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)
  • K771710 — WORRELL PATELLA TEMPLATE (October 6, 1977)
  • K771709 — WORRELL TRIAL PATELLA (October 6, 1977)

FDA data resources