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510(k) K962233

TWIST-OFF SCREW by Landos, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 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)
  • 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)
  • 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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