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510(k) K061776

ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE by Arthrotek, Inc. — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2006
Date Received
June 23, 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.

  • 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)
  • 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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  • K243658 — TMC Compression Implant System (December 26, 2024)
  • K242415 — TMC Compression Implant System (September 6, 2024)
  • K240212 — COGNiTiON™ Staple System (February 23, 2024)
  • K232990 — A’TOMIC™ Nitinol Fixation System (January 12, 2024)
  • K230724 — arcad® 2.0 Duo & Quadro osteosynthesis compressive staples (December 4, 2023)
  • K232905 — Medline UNITE® REFLEX® Nitinol Staple Kit (October 19, 2023)
  • K232324 — StealthFix Intraosseous Fixation System (August 30, 2023)