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510(k) K823837

RMC TOTAL KNEE SYSTEM by Richard'S Medical Equip., Inc. — Product Code MBV

K823837 is an FDA 510(k) premarket notification submitted by Richard'S Medical Equip., Inc. for the device "RMC TOTAL KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 29, 1983. The device falls under product code MBV (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Richard'S Medical Equip., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1983
Date Received
December 21, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

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

  • K830793 — PATIENT GUIDED ELBOW & SHOULDER EXERC (June 16, 1983)
  • K823723 — SPECTRON PROXIMAL FEMORAL PROSTHESIS (March 9, 1983)
  • K823726 — SPECTRON CONVERSION ENDOPROSTHESIS CUP (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)
  • K823725 — SPECTRON PROTRUSIO CUP (January 21, 1983)
  • K823728 — SPECTRON POLYETHYLENE ACCTUBULAR COMPON (January 21, 1983)

Other clearances for product code MBV

  • K010212 — OFFSET TIBIAL TRAY (February 14, 2001)
  • K884824 — TRICON-M TOTAL KNEE SYSTEM (November 21, 1989)
  • K873429 — FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE (October 28, 1987)
  • K853730 — FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP (February 18, 1986)
  • K833200 — TRICON M TOTAL KNEE SYSTEM (November 29, 1983)
  • K831441 — POROCOAT FREEMAN/SAMUELSON TOTAL KNEE (September 1, 1983)
  • K832302 — MARK I TOTAL KNEE SYS. ARTHROPLASTY (August 16, 1983)
  • K830726 — MARK I & II TOTAL KNEE REPLACE. SYS (June 22, 1983)
  • K830408 — FREEMAN/SAMUELSON TOTAL KNEE (February 24, 1983)
  • K822583 — TOTAL KNEE SYSTEM (October 4, 1982)

FDA data resources