FDA 510(k) K202327, Invictus™ OsseoScrew® System, by Alphatec Spine, Inc.
FDA 510(k) K202327, Invictus™ OsseoScrew® System, by Alphatec Spine, Inc.
Device Classification Name: Thoracolumbosacral Pedicle Screw System
510(k) Number: K202327
Device Name: Invictus™ OsseoScrew® System
Applicant: Alphatec Spine, Inc.
Regulation Number: 888.3070
Classification Product Code: NKB
Date Received: 08/17/2020
Decision Date: 10/15/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
510k Review Panel: Orthopedic
Total number of pages: 667
Fully redacted pages: 462
Content pages: 205
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