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510(k) K012702

BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 by Endotec, Inc. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2002
Date Received
August 14, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Endotec, Inc.

  • K081400 — FANNING-PAPPAS MODULAR KNEE BEARING (February 20, 2009)
  • K992394 — BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT (October 15, 1999)
  • K982418 — BUECHEL-PAPPAS MODULAR SALVAGE STEM (April 29, 1999)
  • K963100 — TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF (February 12, 1997)
  • K963101 — B-P HEMISPHERICAL ACETABULAR COMPONENT (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)

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