NANOFIBER SOLUTIONS LLC

FDA Device Registration & Listing · Dublin, OH, US · Registration 3014527904

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014527904
FEI Number
3014527904
Entity Name
NANOFIBER SOLUTIONS LLC
City/State/Country
Dublin, OH, US
Establishment Address
5164 Blazer Parkway, Dublin, OH 43017, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Nanofiber Solutions LLC (Owner Number: 10057315)
Owner / Operator Contact Address
5164 Blazer Parkway, Dublin, OH 43017, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K173544
PMA Number
N/A

All Registered Proprietary Names

Rotium BIOCHARGE Rotium Phoenix Wound Matrix

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2019-03-25
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2024-12-18
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-10-10
QSZ Absorbable Synthetic Wound Dressing Unknown Class U N/A 2018-03-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nanofiber Solutions LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K203334 Acuitive Technologies, Inc. The Citrefix Knotless Suture Anchor 2021-02-05
K243467 Osteonic Co., Ltd. Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) 2024-12-03
K213415 OSSIO , Ltd. OSSIOfiber Suture Anchor 2022-03-28

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014527904. Last updated year: 2026. Please use registration number 3014527904 when referencing this establishment in official correspondence.
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