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510(k) Data Aggregation
K Number
K083626Device Name
DISTRACTABLE WAVE CAGE
Manufacturer
ADVANCED MEDICAL TECHNOLOGY, INC.
Date Cleared
2009-10-19
(315 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED MEDICAL TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The distractable WAVE PLIF Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Distractable WAVE PLIF Cage implants are to be used with autogenous bone graft and implanted via an open posterior approach. The distractable WAVE PLIF Cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Device Description
The distractable WAVE cage is rectangular in shape. Cross section is trapezoidal with the lateral side 1mm higher than the medial. WAVE has a neutral and a 6' lordosis. The posterior end has a threaded hole for attaching insertion instruments, while the other end is solid and tapered. The WAVE cages are implanted in pairs. The distractable WAVE cage is different from the previously cleared WAVE by the ability to distract the implant and restore disc height. Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications).
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