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510(k) Data Aggregation
K Number
K141509Device Name
ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS
Manufacturer
MEDOS SARL
Date Cleared
2014-08-22
(77 days)
Product Code
PGM
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
MEDOS SARL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ISOLA® Growing Spine System is indicated for patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The ISOLA® Growing Spine System may be used with any cleared traditional ISOLA® Spine System 3/16 inch rod constructs.
The EXPEDIUM® Growing Spine System is indicated for patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The EXPEDIUM® Growing System may be used with any cleared traditional 4.5 and 5.5 EXPEDIUM® Spine Systems. The EXPEDIUM® Growing Spine System is not intended to be used with 4.0mm diameter screws.
Device Description
The ISOLA and EXPEDIUM Growing Spine Systems consist of an assortment of connectors designed to convert a traditional fusion construct into a non-fusion growth enabling construct that can be surgically lengthened on a periodic basis as the patient grows. The ISOLA and EXPEDIUM Growing Spine Systems' components are manufactured from titanium alloy and stainless steel and are designed to interact with constructs consisting of rods ranging in diameter from 4.5 to 5.5mm, hooks, screws, offset connectors, and cross connectors. The ISOLA and EXPEDIUM Growing Spine Systems are intended for use only with ISOLA (3/16 inch rod diameter) and EXPEDIUM Spinal Systems (4.5 and 5.5mm rod diameter) fusion constructs for cleared pediatric use.
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