FDA 510(k) K192930, Dymaxeon Spine System, by Back 2 Basics Direct, LLC
FDA 510(k) K192930, Dymaxeon Spine System, by Back 2 Basics Direct, LLC
Device Classification Name: Thoracolumbosacral Pedicle Screw System
510(k) Number: K192930
Device Name: Dymaxeon Spine System
Applicant: Back 2 Basics Direct, LLC
Regulation Number: 888.307
Classification Product Code: NKB
Date Received: 2019-10-17
Decision Date: 2020-05-12
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
510k Review Panel: Orthopedic
Total number of pages: 471
Fully redacted pages: 325
Content pages: 146
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