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510(k) Data Aggregation
K Number
K071824Device Name
ACME TALON PEDICLE SCREW
Manufacturer
ACME SPINE, LLC.
Date Cleared
2007-09-04
(63 days)
Product Code
MNI, KWP, MNH
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
ACME SPINE, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Acme Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
Device Description
The Acme Spinal System consists of monoaxial and polyaxial pedicle screws, locking plugs, spinal rods and rod to rod connectors. Acme Spine System can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. The modification included in this submission is the addition of the Acme Talon Pedicle Screw.
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K Number
K001044Device Name
ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM
Manufacturer
ACME SPINE, LLC.
Date Cleared
2000-11-03
(217 days)
Product Code
MNH
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
ACME SPINE, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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