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510(k) K962236

SCARF THREAD-HEAD SCREW by Landos, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1996
Date Received
June 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Landos, Inc.

  • K964226 — MEMORY STAPLE (20 SIZES AVAILABLE) (August 5, 1997)
  • K971070 — SCARF THREAD-HEAD (TM) HEAD SCREW (July 9, 1997)
  • K971068 — 34MM SCARF THREAD-HEAD(TM) 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)
  • K960642 — NANCY NAIL (May 17, 1996)
  • K943727 — BIOSTOP G BONE CEMENT RESTRICTOR (May 11, 1995)

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