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510(k) K923911

INTRINSIC STEM by Turnkey Intergration USA, Inc. — Product Code LWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1993
Date Received
August 4, 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

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  • K970284 — ARTOS, DIPLOS SYSTEM (April 21, 1997)
  • K970084 — LINK CERCLAGE WIRE SYSTEM (March 13, 1997)
  • K953653 — LUBINUS SP II HIP SYSTEM (November 6, 1995)
  • K943986 — LINK ENDO MODEL REVISION CUP (July 5, 1995)
  • K951355 — LINK SADDLE PROTHESIS (May 25, 1995)
  • K950397 — SYSTEM 22 VALVE (April 14, 1995)

Other clearances for product code LWJ

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  • K082146 — METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD (September 9, 2008)
  • K070061 — 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT (January 31, 2007)
  • 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)