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510(k) K910128

LEVTECH TITANIUM BONE WIRE by Levtech, Inc. — Product Code JDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1991
Date Received
January 9, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cerclage, Fixation
Device Class
Class II
Regulation Number
888.3010
Review Panel
OR
Submission Type

Other clearances by Levtech, Inc.

  • K901144 — LEVTECH BONE SCREW (October 10, 1990)
  • K873693 — LEVTECH COMPOSITE TRACTION TONGS (February 5, 1988)
  • K874023 — LEVTECH CLAMP APPLIER (November 6, 1987)
  • K850039 — HALIFAX SPINAL CLAMP (May 29, 1985)

Other clearances for product code JDQ

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  • K232733 — Mbrace Cable (May 3, 2024)
  • K233949 — ACCORD Cable System (March 13, 2024)
  • K232986 — VariTrax Sternal CircumFixation System (January 30, 2024)
  • K230976 — Arthrex Radiopaque FiberTape Cerclage sutures (August 24, 2023)
  • K231333 — STRETTO™ Cable System (August 4, 2023)
  • K220765 — HS Fiber Cerclage (July 26, 2023)
  • K221795 — STERN FIX Sternal Stabilization System (October 19, 2022)
  • K211613 — Stern Fix Sternal Stabilization System (January 19, 2022)