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510(k) K010633

RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM by Mitek Products — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2001
Date Received
March 2, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Mitek Products

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  • K002406 — MITEK 2GII MENISCAL REPAIR SYSTEM (February 15, 2001)
  • K003076 — MITEK CUFFTACK (October 27, 2000)
  • K002402 — VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM (August 31, 2000)
  • K002422 — VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR 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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