Precision Spine Announces 510(k) Clearance, Launch of Cervical Fusion Device
Parsippany, N.J.-based Precision Spine said Thursday it has launched the Vault-C Anterior Cervical Interbody Fusion Device, following receipt of FDA 510(k) clearance. The device is the latest in the company’s Precision Spine cervical product portfolio.
The Vault-C allows for a rigid screw fixation using a zero profile design that limits the risk of damage to surrounding vessels and soft tissue. Surgeons can choose from two titanium alloy screws — self-drilling/self-tapping or blunt-tip/self-tapping — and have visual confirmation that the screw is in place via its locking mechanism. The screws are filled with an autogenous bone graft material to simplify fusion, the company said.
Rich Dickerson, president of Precision Spine, said the Vault-C “offers surgeons an additional treatment option, allowing for easier access to challenging levels of the cervical spine, with a true zero profile construct.”
The device is intended for patients with degenerative disc disease who have had six weeks of nonsurgical treatment. — Kellen Owings
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