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510(k) K053461

EZLOC FEMORAL FIXATION DEVICE by Arthrotek, Inc. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2006
Date Received
December 13, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Arthrotek, Inc.

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  • K061657 — HITCH LACTOSORB SUTURE ANCHOR (July 25, 2006)
  • K061389 — ALLTHREAD LACTOSORB SUTURE ANCHOR (July 19, 2006)
  • K060693 — MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR (June 6, 2006)
  • K051069 — NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER (June 29, 2005)
  • K042460 — TI - SCREW ANCHOR SP (October 29, 2004)
  • K041274 — RESORBABLE INTERFERENCE SCREW (July 28, 2004)
  • K041261 — FEMORAL HOOK (June 7, 2004)
  • K040604 — INNERVUE DIAGNOSTIC SCOPE SYSTEM (June 4, 2004)

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