Search Results
Found 1 results
510(k) Data Aggregation
K Number
K122085Device Name
STINGRAY CERVICAL CAGE
Manufacturer
OMNI SURGICAL, LP DBA SPINE360
Date Cleared
2012-10-17
(93 days)
Product Code
ODP
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
OMNI SURGICAL, LP DBA SPINE360
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spine360 Stingray Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Spine 360 Cervical Interbody Fusion System implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to T1 disc levels using autograft bone. The Spine 360 Cervical Interbody Fusion System implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Device Description
The Stingray Cervical Cage was developed as an intercorporal implant for anterior cervical spondylosis. Stingray is a system of wedge-shaped implants and instruments designed for anterior cervical interbody fusion (ACF). In the lateral view, the implant has a 3.5° lordotic form. The Stingray Cervical Cage has a flat top and bottom. Materials: PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) and tantalum according to ASTM F560.
Ask a Question
Page 1 of 1