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510(k) K211996

Nexta PEEK Hammertoe Correction System by Nextremity Solutions, Inc. — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2021
Date Received
June 28, 2021
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 Nextremity Solutions, Inc.

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  • K220181 — StealthFix Intraosseous Fixation System (March 22, 2022)
  • 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)
  • 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)
  • K192578 — InCore TMT System (December 31, 2019)

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