Atlas FDA

Flow-Nail

FDA 510(k) clearance K234075 · decided 2024-02-05

Clearance details

K-number
K234075
Device name
Flow-Nail
Applicant
Flow-Fx, LLC
Decision
Substantially Equivalent
Date received
2024-01-10
Decision date
2024-02-05
Days to decision
26 days
Clearance type
Special
Product code
HSB
Device class
2
Regulation number
888.3020
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Mokena, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Pangea Femur Reconstruction System (K261481)Stryker GmbH2026-06-29
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AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) (K253080)Suzhou and Science & Technology Development Corp.2026-06-18
Fule Metallic Lockable Intramedullary Nail Systems (K253155)Beijing Fule Science & Technology Development Co., Ltd.2026-06-17
HERA Interlocking Intramedullary Nailing System (K253046)ZheJiang Decans Medical Devices Co., Ltd.2026-06-16
FITBONE® TRANSPORT AND LENGTHENING SYSTEM (K260146)Orthofix Srl2026-05-19
Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA (K253991)Orthofix Srl2026-05-08
AUTOBAHN™ Nailing System (K261043)Globus Medical, Inc.2026-04-24
Arthrex Humeral Nails (K252016)Arthrex, Inc.2026-03-20
Fusion FibFix Nail (K252961)Fusion Orthopedics USA, LLC2026-03-18
Affixus Retrograde Femoral Nailing System (K253566)Zimmer, Inc.2026-03-12
Reselute Tibial Nail (K253517)Reselute, Inc.2026-03-10

Recalls involving this device

No recalls on record reference this clearance.