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510(k) K982418

BUECHEL-PAPPAS MODULAR SALVAGE STEM by Endotec, Inc. — Product Code MJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1999
Date Received
July 13, 1998
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented
Device Class
Class III
Regulation Number
Review Panel
OR
Submission Type

Other clearances by Endotec, Inc.

  • K081400 — FANNING-PAPPAS MODULAR KNEE BEARING (February 20, 2009)
  • K012702 — BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 (January 30, 2002)
  • K992394 — BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT (October 15, 1999)
  • K963101 — B-P HEMISPHERICAL ACETABULAR COMPONENT (February 12, 1997)
  • K963100 — TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF (February 12, 1997)
  • K960425 — BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX (October 3, 1996)
  • K960424 — BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD (August 26, 1996)
  • K945254 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES (June 6, 1995)
  • K944465 — CARRIER, LIGATURE (79 GEJ) (September 28, 1994)
  • K944414 — DEKALB (September 27, 1994)

Other clearances for product code MJT

  • K990712 — OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM (July 20, 1999)
  • K960363 — BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101 (February 18, 1997)