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510(k) K823726

SPECTRON CONVERSION ENDOPROSTHESIS CUP by Richard'S Medical Equip., Inc. — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1983
Date Received
December 10, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
Review Panel
OR
Submission Type

Other clearances by Richard'S Medical Equip., Inc.

  • K830793 — PATIENT GUIDED ELBOW & SHOULDER EXERC (June 16, 1983)
  • K823837 — RMC TOTAL KNEE SYSTEM (March 29, 1983)
  • K823723 — SPECTRON PROXIMAL FEMORAL PROSTHESIS (March 9, 1983)
  • K823724 — SPECTRON NECK REPLACEMENT PROSTHESIS (March 9, 1983)
  • K823727 — SPECTRON PRIMARY STEM FEMORAL PROSTHES (March 8, 1983)
  • K823722 — SPECTRON LONG, STRAIGHT FEMORAL PROSTHES (March 8, 1983)
  • K830153 — RICHARDS INTRA-ARTICULAR SHAVER BLADES (February 28, 1983)
  • K830154 — COLLES FRACTURE FRAME (February 2, 1983)
  • K823729 — SPECTRON METAL BACK ACETABULAR COMPONENT (January 21, 1983)
  • K823728 — SPECTRON POLYETHYLENE ACCTUBULAR COMPON (January 21, 1983)

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