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510(k) K901594

H.N. TOTAL HIP PROSTHESIS by Med-Tek Corp. — Product Code LWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1990
Date Received
April 5, 1990
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 Med-Tek Corp.

  • K903234 — F-19 TOTAL HIP PROSTHESIS (October 10, 1990)
  • K901687 — F-24 FEMORAL HIP PROSTHESIS (September 7, 1990)
  • K901451 — F-20 CEMENTED METAL-BACKED ACETABULAR CUP (August 31, 1990)
  • K900428 — ANESTHESIA BREATHING CIRCUITS (August 17, 1990)
  • K901626 — H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED (August 14, 1990)
  • K901480 — F-20 TOTAL HIP PROSTHESIS (June 12, 1990)
  • K901273 — L.M.S. SELF-DETACHABLE BROACH WITH STOP (June 5, 1990)
  • K901272 — ORION BLADE PLATE FOR TIBIAL OSTEOTOMY (April 23, 1990)
  • K901240 — ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED (March 26, 1990)
  • K894978 — BACTERIAL FILTER (November 2, 1989)

Other clearances for product code LWJ

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  • K103518 — TRINITY ACETABULAR SYSTEM (March 9, 2011)
  • K090764 — NOVATION CFS PRESS-FIT AND CEMENTED STEMS (April 21, 2009)
  • 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)