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510(k) K002406

MITEK 2GII MENISCAL REPAIR SYSTEM by Mitek Products — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2001
Date Received
August 7, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Mitek Products

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  • K010633 — RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM (May 9, 2001)
  • K003076 — MITEK CUFFTACK (October 27, 2000)
  • K002422 — VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM (August 31, 2000)
  • K002402 — VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM (August 31, 2000)
  • K000936 — VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM (April 19, 2000)
  • K993575 — RESOLVE QUICKANCHOR (December 29, 1999)
  • K993327 — TALON ANCHOR SNAP-PAK (December 16, 1999)

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