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510(k) K952629

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1995
Date Received
June 8, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

Other clearances by Nexmed, Inc.

  • K033580 — NEXFLEX TOTAL HIP SYSTEM (August 5, 2004)
  • K991882 — NEXFLEX TOTAL KNEE SYSTEM (December 8, 1999)
  • K955170 — NEXFLEX FEMORAL STEM, STANDARD DESIGN (February 9, 1996)
  • K955171 — NEXLOCK FEMORAL STEM (February 9, 1996)
  • K951656 — NEXMED CANCELLOUS BONE SCREWS (July 18, 1995)

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