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510(k) K913461

FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM by Neoligaments, Ltd. — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1991
Date Received
August 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Neoligaments, Ltd.

  • K941772 — CRADLE FIXATION DEVICE (August 7, 1995)
  • K952543 — GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SET (June 22, 1995)
  • K935753 — THE GRAFTOLOGER (April 25, 1994)
  • K930339 — REAMER BIT (August 6, 1993)
  • K911445 — FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM (June 28, 1991)
  • K904340 — FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM (October 19, 1990)

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