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510(k) K014305

RESORBABLE LACTOSORB-L ACL CROSSPIN by Arthrotek, Inc. — Product Code HTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2002
Date Received
December 31, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Smooth
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K053461 — EZLOC FEMORAL FIXATION DEVICE (February 3, 2006)
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  • K042460 — TI - SCREW ANCHOR SP (October 29, 2004)
  • K041274 — RESORBABLE INTERFERENCE SCREW (July 28, 2004)
  • K041261 — FEMORAL HOOK (June 7, 2004)

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