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510(k) K033580

NEXFLEX TOTAL HIP SYSTEM by Nexmed, Inc. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2004
Date Received
November 13, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

Other clearances by Nexmed, Inc.

  • K991882 — NEXFLEX TOTAL KNEE SYSTEM (December 8, 1999)
  • K955170 — NEXFLEX FEMORAL STEM, STANDARD DESIGN (February 9, 1996)
  • K955171 — NEXLOCK FEMORAL STEM (February 9, 1996)
  • K952629 — NEXFLEX TOTAL HIP SYSTEM (September 8, 1995)
  • K951656 — NEXMED CANCELLOUS BONE SCREWS (July 18, 1995)

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