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510(k) Data Aggregation
K Number
K200170Device Name
SpineNet SSP System
Manufacturer
Date Cleared
2020-02-05
(13 days)
Product Code
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
SpineNet LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SpineNet SSP System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion.
Device Description
The SpineNet SSP System is an anterior cervical plate and screw system which includes fixed and variable self-tapping screws and one- through four level plates. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.
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