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510(k) K042460

TI - SCREW ANCHOR SP by Arthrotek, Inc. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2004
Date Received
September 10, 2004
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.

  • K061776 — ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE (September 25, 2006)
  • K061801 — 2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS (August 7, 2006)
  • 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)
  • K053461 — EZLOC FEMORAL FIXATION DEVICE (February 3, 2006)
  • K051069 — NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER (June 29, 2005)
  • 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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