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510(k) K844960

CANAL WALL PROSTHESIS by Richards Medical Co., Inc. — Product Code FZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1985
Date Received
December 21, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Ear, Internal
Device Class
Class II
Regulation Number
878.3590
Review Panel
SU
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)

Other clearances for product code FZD

  • K172389 — ePTFE-Coated Auricular Implant (July 18, 2018)
  • K863939 — POREX(TM) EAR PROSTHESIS (October 24, 1986)