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510(k) Data Aggregation
K Number
K111484Device Name
DISCOVERY
Manufacturer
INTUITIVE SPINE, LLC
Date Cleared
2011-09-12
(104 days)
Product Code
ODP
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
INTUITIVE SPINE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DISCOVERY is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.
Device Description
The DISCOVERY is a cervical interbertebral body fusion device consisting of teeth on the inferior and superior surfaces to prevent back out and migration. The profile of the device is rectangular with a hollow core for bone graft to promote bone integration and fusion between the endplates. The device is available in various heights accommodate variability among patients and is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560.
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