FDA.report

510(k) K231807

Device
primaLOK™ SP Interspinous Fusion System
Applicant
Wenzel Spine, Inc.
510(k) number
K231807
Product code
PEK
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-15
Date received
2023-06-20
Regulation
888.3050
Classification name
Spinous Process Plate
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
William Wilson
Address
1130 Rutherford Ln. Suite 200 Austin TX US 78753 78753

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K180817AERIAL™ Interspinous FixationGlobus Medical, Inc.2018-05-21
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