Home / 510(k) Clearances / K955171

510(k) K955171

NEXLOCK FEMORAL STEM by Nexmed, Inc. — Product Code JDG

K955171 is an FDA 510(k) premarket notification submitted by Nexmed, Inc. for the device "NEXLOCK FEMORAL STEM". The FDA issued a decision of Substantially Equivalent on February 9, 1996. The device falls under product code JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal), a Class II device regulated under 21 CFR 888.3360. Nexmed, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1996
Date Received
November 13, 1995
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 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)
  • K952629 — NEXFLEX TOTAL HIP SYSTEM (September 8, 1995)
  • K951656 — NEXMED CANCELLOUS BONE SCREWS (July 18, 1995)

Other clearances for product code JDG

  • K212431 — Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve (February 7, 2022)
  • 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)
  • 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)
  • K951083 — PROFORM CEMENTED FEMORAL COMPONENT (May 22, 1995)

FDA data resources