Home / 510(k) Clearances / K061801

510(k) K061801

2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS by Arthrotek, Inc. — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2006
Date Received
June 26, 2006
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 Arthrotek, Inc.

  • K061776 — ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE (September 25, 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)
  • 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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