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510(k) K812687

BRIGHAM II TOTAL HIP SYSTEM by Hexcel Medical — Product Code JDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1981
Date Received
September 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

Other clearances by Hexcel Medical

  • K840416 — HEXCELITE (March 23, 1984)
  • K820890 — URETHANE ORTHOPAEDIC CASTING TAPE (June 23, 1982)
  • K812669 — SEATTLE II TOTAL HIP SYSTEM (October 2, 1981)
  • K812068 — PROPOSED CONTROLS FOR DOSIMETRIC RELEASE (September 8, 1981)
  • K811164 — URETHANE ORTHOPAEDIC CASTING TAPE (May 27, 1981)
  • K810957 — MARCOVE INTRAMEDULLARY ROD (April 17, 1981)
  • K810956 — MARCOVE HUMERAL ROD (April 17, 1981)
  • K810230 — CONDYLAR KNEE W/METAL ENCAPSULATED TIB (March 6, 1981)
  • K800051 — HEXCEL FEMORAL COMPONENT HIP PROSTHESIS (January 28, 1980)
  • K800050 — ANITOMIC TOTAL HIP SYSTEM (January 24, 1980)

Other clearances for product code JDG

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  • K193546 — Distal Centralizers (September 25, 2020)
  • K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (March 19, 2018)
  • K001984 — PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT (September 27, 2000)
  • K992234 — THE TAPER-FIT TOTAL HIP SYSTEM (November 10, 1999)
  • K962002 — AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM (August 8, 1996)
  • K955171 — NEXLOCK FEMORAL STEM (February 9, 1996)
  • K953653 — LUBINUS SP II HIP SYSTEM (November 6, 1995)
  • K953067 — HIP FRACTURE STEM FENESTRATION PLUG (August 21, 1995)
  • K945783 — ORTHOMET TITANIUM HYBRID FEMORAL STEM (May 30, 1995)