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510(k) K890331

FREEMAN TOTAL HIP SYSTEM RIDGED STEM by Orthopedic Systems, Inc. — Product Code LWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1989
Date Received
January 23, 1989
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

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  • K896678 — SILICONE PLUG (January 30, 1990)
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  • K890498 — FREEMAN MODULAR HIP STEM RIDGED VERSION (October 13, 1989)
  • K895219 — CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM (September 12, 1989)

Other clearances for product code LWJ

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  • K062978 — U2 HIP STEM, TI PLASMA SPRAY (January 16, 2007)
  • K062383 — UNISYN HA PLASMA MODULAR HIP (December 21, 2006)
  • K061699 — EXCIA (August 18, 2006)
  • K051826 — BETACONE HIP PROSTHESIS SYSTEM (November 18, 2005)
  • K050262 — U2 ACETABULAR COMPONENT (August 15, 2005)