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510(k) Data Aggregation
K Number
K163011Device Name
PHA S1 Spinal System
Manufacturer
Phamedica, Inc.
Date Cleared
2017-06-29
(244 days)
Product Code
NKB
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Phamedica, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Phamedica PHA S1 Spinal System is intended for posterior non-cervical pedicle fixation of Thoracic, Lumbar, Sacral/ Iliac Spine in skeletally mature patients, as an adjunct to fusion using autogeneous bone graft or all of the following indications:
· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- · Spondylolisthesis
- · Trauma (i.e., fracture or dislocation)
- · Spinal Stenosis
- · Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudoarthrosis
- · Failed previous fusion in skeletally mature patients.
Device Description
Phamedica PHA S1 Spinal Fixation system consists of Poly Axial screws, Mono Axial Screws, Poly Axial and Mono Axial Reduction Screws, Rods, Set Screws, Transverse and Offset connectors made from Titanium Alloy Ti6AL4V which can be variously assembled for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine.
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