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510(k) K123926

METASURG NITINOL STAPLE IMPLANT by Metasurg — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2013
Date Received
December 20, 2012
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 Metasurg

  • K111265 — METASURG SUBTALAR IMPLANT (August 9, 2011)
  • 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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  • 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)
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