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510(k) K896580

UNI-POLAR HEAD by Richards Medical Co., Inc. — Product Code LZY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1990
Date Received
November 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Device Class
Class II
Regulation Number
888.3360
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)
  • 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)
  • K890132 — POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP. (July 19, 1989)

Other clearances for product code LZY

  • K231448 — TANDEM Hip System (July 19, 2023)
  • K111145 — ENDO HEAD (August 16, 2011)
  • K974442 — PRE-POWDERED NITRILE EXAMINATION GLOVES (January 5, 1998)
  • K915528 — BHR BIPOLAR FEMORAL HEAD COMPONENT (June 29, 1993)
  • K915548 — IONGUARD TITANIUM MODULAR HEADS (March 10, 1992)
  • K903084 — MODULAR CATHCART FRACTURE SYSTEM (October 3, 1990)
  • K892059 — FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR (July 19, 1989)