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510(k) K881117

RESUBMITTING OF HJD TOTAL HIP SYSTEM by Richards Medical Co., Inc. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1988
Date Received
March 9, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
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)
  • K895241 — INTRAMEDULLARY HIP SCREW (January 4, 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)

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