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510(k) K991882

NEXFLEX TOTAL KNEE SYSTEM by Nexmed, Inc. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1999
Date Received
June 2, 1999
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 Nexmed, Inc.

  • K033580 — NEXFLEX TOTAL HIP SYSTEM (August 5, 2004)
  • 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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