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510(k) K111265

METASURG SUBTALAR IMPLANT by Metasurg — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2011
Date Received
May 4, 2011
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 Metasurg

  • K123926 — METASURG NITINOL STAPLE IMPLANT (May 3, 2013)
  • K111536 — METASURG DIGIFUSE IMPLANT (July 21, 2011)
  • K083469 — METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 (February 13, 2009)
  • K070441 — METASURG SUBTALAR IMPLANT (May 8, 2007)

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