510(k) clearances

Rotium

Nanofiber Solutions, LLC · General, Plastic Surgery

K250021Substantially EquivalentTraditionalOWW
Open FDA's page for this record
Third party flag
N
City
Dublin
Advisory committee description
General, Plastic Surgery
Address 1
5164 Blazer Pkwy.
Statement or summary
Summary
Product code
OWW
Zip code
43017
Applicant
Nanofiber Solutions, LLC
Decision date
2025-02-27
Decision code
SESE
Country code
US
Device name
Rotium
Advisory committee
SU
Contact
Jason Chakroff
K number
K250021
State
OH
Date received
2025-01-03
Review advisory committee
OR
Postal code
43017
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Medical specialty description
General, Plastic Surgery
Regulation number
878.3300
Device class
2
Registration number
3033273526, 3009493875, 3033302333, 1320894, 3014527904, 3019101334, 1017294, 2030598, 3012669262, 8043792, 3010673515, 1064858, 3000215346, 1721676, 3027699572, 9614442
FEI number
3033273526, 3009493875, 3033302333, 3027699572, 3002808269, 3014527904, 3019101334, 3010673515, 1017294, 3008397795, 3012669262, 3000215346, 3001451571, 1721676, 1000518731, 3000303710
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.