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510(k) K033718

MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE by Arthrotek, Inc. — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2004
Date Received
November 26, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

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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)
  • 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)

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