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510(k) K182201

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2018
Date Received
August 14, 2018
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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  • 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)
  • K200785 — Stratum™ Reduced Size Foot Plating System (July 27, 2020)
  • K200840 — DuoHex CH Cannulated Hammertoe System (June 26, 2020)
  • K200124 — InCore MPJ System (May 13, 2020)

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  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
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  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
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  • K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System (January 21, 2026)
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