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510(k) K932935

TITAN DYSPLASIC TOTAL HIP PROSTHESIS by Landos, Inc. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1994
Date Received
June 16, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

Other clearances by Landos, Inc.

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  • K971068 — 34MM SCARF THREAD-HEAD(TM) SCREW (July 9, 1997)
  • K971070 — SCARF THREAD-HEAD (TM) HEAD SCREW (July 9, 1997)
  • K971069 — TWIST-OFF (TM) SCREW (July 9, 1997)
  • K961732 — KAR (July 8, 1997)
  • K970846 — 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD (June 5, 1997)
  • K953111 — CORAIL (December 27, 1996)
  • K962233 — TWIST-OFF SCREW (October 3, 1996)
  • K962236 — SCARF THREAD-HEAD SCREW (September 20, 1996)
  • K960642 — NANCY NAIL (May 17, 1996)

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