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510(k) K200785

Stratum™ Reduced Size Foot Plating System by Nextremity Solutions, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2020
Date Received
March 26, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K213301 — InCore Subtalar System (December 21, 2021)
  • K213530 — Nextra CH Cannulated Hammertoe System (December 9, 2021)
  • K212640 — Stratum® Ankle Fusion Plating System (November 18, 2021)
  • K211996 — Nexta PEEK Hammertoe Correction System (September 23, 2021)
  • K200840 — DuoHex CH Cannulated Hammertoe System (June 26, 2020)
  • K200124 — InCore MPJ System (May 13, 2020)
  • K192578 — InCore TMT System (December 31, 2019)

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