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510(k) K970846

22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD by Landos, Inc. — Product Code LZO

Clearance Details

Decision
SN ()
Decision Date
June 5, 1997
Date Received
March 7, 1997
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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  • K971070 — SCARF THREAD-HEAD (TM) HEAD SCREW (July 9, 1997)
  • K971069 — TWIST-OFF (TM) SCREW (July 9, 1997)
  • K961732 — KAR (July 8, 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)
  • K943727 — BIOSTOP G BONE CEMENT RESTRICTOR (May 11, 1995)

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