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510(k) K895241

INTRAMEDULLARY HIP SCREW by Richards Medical Co., Inc. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1990
Date Received
August 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Richards Medical Co., Inc.

  • K896106 — ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS (June 25, 1990)
  • K900628 — MODULAR HIP SYSTEM (May 9, 1990)
  • K896580 — UNI-POLAR HEAD (February 15, 1990)
  • K884824 — TRICON-M TOTAL KNEE SYSTEM (November 21, 1989)
  • K896204 — ZIRCONIA CERAMIC HEAD ADD'L SIZES (November 20, 1989)
  • K895242 — PAPPAS TRI-FLANGE VENTILATION TUBE (November 17, 1989)
  • K893377 — RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS (November 16, 1989)
  • K885069 — ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED) (September 1, 1989)
  • K892366 — POROUS GENESIS STEMMED TIBIAL COMPONENT (July 19, 1989)
  • K890132 — POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP. (July 19, 1989)

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