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510(k) K921382

FUTURA TEXTURE-TRAKKED TOTAL HIP STEM by Arthronics, Inc. — Product Code LWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1994
Date Received
March 23, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

Other clearances by Arthronics, Inc.

  • K931107 — LOGYK ACETABULAR COMPONENT SYSTEM (March 28, 1994)

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  • K050262 — U2 ACETABULAR COMPONENT (August 15, 2005)