Search Results
Found 2 results
510(k) Data Aggregation
K Number
K141123Device Name
ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM
Manufacturer
ALLIANCE PARTNERS, LLC.
Date Cleared
2015-02-27
(302 days)
Product Code
GWO, GXR, HBW
Regulation Number
882.5320Why did this record match?
Applicant Name (Manufacturer) :
ALLIANCE PARTNERS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Alliance Spine RAAS Cranial Plating System is indicated for osteotomies, cranial fractures, and reconstruction of non-load bearing cranial areas.
Device Description
The Alliance Spine RAAS Cranial Plating System consists of various sizes and geometries of malleable low profile cranial plates including straight, box, and gap plates, burr hole covers, malleable mesh as well as fasteners (screws) that provide stable internal fixation of cranial fractures and bone flaps, as well as coverage and stabilization of burr holes and other cranial defects. The RAAS plates and burr hole covers are 0.5mm thick, while the RAAS malleable Mesh is supplied in 0.3mm and 0.6mm thickness. The fasteners (screws) are supplied in 1.5mm diameter Self-Drilling and 1.5mm diameter Self-Tapping configurations in 4mm and 5mm lengths, while the RAAS Rescue Screws are 1.7mm in diameter in 5mm and 6mm lengths. The Screws and Mesh are color anodized for identification.
Ask a Question
K Number
K140303Device Name
ALAMO T
Manufacturer
ALLIANCE PARTNERS, LLC.
Date Cleared
2014-04-21
(74 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
ALLIANCE PARTNERS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Alamo T device is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via a transforaminal approach.
Device Description
The Alamo T device is used for spinal fusion surgery to provide support and structural stability at the fusion site following discectomy. The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization. Supplemental fixation and autograft is required to facilitate fusion.
The device footprint has a hollow center to accommodate bone graft and is implanted via a transforaminal (TLIF) surgical approach. The device is available in various heights and lengths to accommodate variability among patients and the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration.
The purpose of this submission is to introduce a range of line extension sizes and make dimensional modifications to the implants and inserter instrument. The new sizes and design modifications do not affect the device's intended use or alter the device's fundamental scientific technology.
Ask a Question
Page 1 of 1