Home / 510(k) Clearances / K904879

510(k) K904879

BEUCHEL-PAPPAS GLENOID COMPONENT by Endotec, Inc. — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1991
Date Received
October 30, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3660
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)
  • 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)

Other clearances for product code KWS

  • K252418 — Catalyst F1x Shoulder System (November 6, 2025)
  • K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0 (October 29, 2025)
  • K241292 — MyShoulder Planner (5.3SSWPL) (January 30, 2025)
  • K241878 — Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral Sys (December 6, 2024)
  • K241609 — Tornier Humeral Reconstruction System (Tornier HRS) (September 10, 2024)
  • K230513 — Arthrex Univers Apex OptiFit Humeral Stem (September 26, 2023)
  • K222592 — AltiVate® Anatomic Shoulder AG e+™ with Markers (June 23, 2023)
  • K230572 — AETOS Shoulder System (June 7, 2023)
  • K220847 — AETOS Shoulder System (January 3, 2023)
  • K222317 — Catalyst EA Convertible Stemmed Shoulder (November 10, 2022)