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510(k) K901144

LEVTECH BONE SCREW by Levtech, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1990
Date Received
March 12, 1990
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 Levtech, Inc.

  • K910128 — LEVTECH TITANIUM BONE WIRE (June 18, 1991)
  • K873693 — LEVTECH COMPOSITE TRACTION TONGS (February 5, 1988)
  • K874023 — LEVTECH CLAMP APPLIER (November 6, 1987)
  • K850039 — HALIFAX SPINAL CLAMP (May 29, 1985)

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