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510(k) K081400

FANNING-PAPPAS MODULAR KNEE BEARING by Endotec, Inc. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2009
Date Received
May 19, 2008
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.

  • 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)
  • K982418 — BUECHEL-PAPPAS MODULAR SALVAGE STEM (April 29, 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)

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