510(k) clearances

Freedom Nail Ankle Fusion System

McGinley Orthopaedic Innovations · Orthopedic

K261189Substantially EquivalentTraditionalHSB
Open FDA's page for this record
Third party flag
N
City
Casper
Advisory committee description
Orthopedic
Address 1
234 E. 1st St. Suite 242
Statement or summary
Summary
Product code
HSB
Zip code
82601
Applicant
McGinley Orthopaedic Innovations
Decision date
2026-10-19
Decision code
SESE
Country code
US
Device name
Freedom Nail Ankle Fusion System
Advisory committee
OR
Contact
Adam Johnson
K number
K261189
State
WY
Date received
2026-04-10
Review advisory committee
OR
Postal code
82601
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Rod, Fixation, Intramedullary And Accessories
Medical specialty description
Orthopedic
Regulation number
888.3020
Device class
2
Registration number
9617297, 3009455196, 3017521423, 3008868758, 1822565, 3014833750, 8043792, 3014302784, 3010287737, 3015876273, 3015877656, 3021008900, 3004450489, 1835572, 1226544, 9614438, 3008837339, 3007366790, 3008749819, 3008514120, 3006801265, 3025141, 3009381600, 3010364775, 3015212339, 3007993775, 1644408, 3007125392, 3013302242, 3016727307, 3006742481, 2134285, 3012392319, 3014527928, 3006846753, 3000327445, 3030412764, 3011388423, 3003477135, 3015216945 +265 more
FEI number
3009455196, 3000718490, 3017521423, 3008868758, 3014833750, 3015876273, 3014302784, 3010287737, 3015877656, 3021008900, 3004450489, 3002807036, 3008837339, 3008749819, 3008514120, 3006801265, 3009381600, 3010364775, 3015212339, 3007993775, 1000139987, 3002808269, 3007125392, 3013302242, 3016727307, 3006742481, 1000306303, 3012392319, 3003414678, 3007282753, 3014527928, 3006846753, 3002807231, 3000327445, 3003015552, 3030412764, 3011388423, 3003477135, 3015216945, 3026593233 +265 more
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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.