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APEX 3D S Diamond Tibia (K261120): 510(k) cleared for Paragon 28, Inc. vs Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations: FDAPulse comparison

Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations's review days of 192 is 1.0x APEX 3D S Diamond Tibia (K261120): 510(k) cleared for Paragon 28, Inc.'s 187 (68th percentile). APEX 3D S Diamond Tibia (K261120): 510(k) cleared for Paragon 28, Inc. is dated 2026-10-07; Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations 2026-10-19.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe

How does APEX 3D S Diamond Tibia (K261120): 510(k) cleared for Paragon 28, Inc. compare to Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations?

FieldAPEX 3D S Diamond Tibia (K261120): 510(k) cleared for Paragon 28, Inc.Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations
Record510(k) clearance510(k) clearance
510(k) numberK261120K261189
DeviceAPEX 3D S Diamond TibiaFreedom Nail Ankle Fusion System
ApplicantParagon 28, Inc.McGinley Orthopaedic Innovations
Specialty / panelOrthopedicOrthopedic
Product codeHSNHSB
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-04-032026-04-10
Decision date2026-10-072026-10-19
Review time (days)187192
Third-party reviewNoNo
Applicant locationEnglewood, CO, USCasper, WY, US
amount percentile66th68th
Predicate Speed & CAPA Advisory Opportunity Score48/10048/100
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Official records: APEX 3D S Diamond Tibia (K261120): 510(k) cleared for Paragon 28, Inc. · Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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