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Inspan ScrewLES Fusion System — Lespine Innovations, LLC (510(k) K213266)

Inspan ScrewLES Fusion System — Lespine Innovations, LLC (510(k) K213266) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Inspan ScrewLES Fusion System; Applicant: Lespine Innovations, LLC; Clearance track: 510(k).

Device nameInspan ScrewLES Fusion System
ApplicantLespine Innovations, LLC
Clearance track510(k)
Submission numberK213266
DecisionSubstantially Equivalent
Decision date2021-12-03
Date received2021-09-30
Product codePEK
Device class2
Medical specialtyOrthopedic
Applicant locationMA, US
SourceopenFDA device

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