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510(k) K201414

Rotium Bioresorbable Wick by Nanofiber Solutions, LLC — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2020
Date Received
May 29, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Nanofiber Solutions, LLC

  • K250021 — Rotium (February 27, 2025)
  • K241912 — BIOCHARGE (July 29, 2024)
  • K231641 — Rotium Bioresorbable Wick (July 5, 2023)
  • K183236 — Rotium Bioresorbable Wick (March 11, 2019)
  • K173544 — Phoenix Wound Matrix (March 2, 2018)

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