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510(k) Data Aggregation
K Number
K081240Device Name
TIGER DISCECTOMY DEVICE
Manufacturer
SPINAL DEVICES, LLC
Date Cleared
2009-02-27
(302 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
SPINAL DEVICES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tiger Discectomy Device is indicated for use in endoscopic and non-endoscopic spinal procedures to assist in the removal of fibrous disc material between the T12 to S1 spinal segments.
Device Description
The Tiger Discectomy Device is a single-use manual instrument. The components of the device include a "T" handle, a shaft, two cutting blades and blade holder, retaining pins and a blunt tip. Cutting blades are available in 8mm, 10mm and 12mm widths. A cannula is provided for endoscopic applications. The device is provided sterile.
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K Number
K083167Device Name
PHENIX CERVICAL INTERBODY DEVICE
Manufacturer
SPINAL DEVICES, LLC
Date Cleared
2009-01-13
(78 days)
Product Code
ODP
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
SPINAL DEVICES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Phenix Cervical Interbody Device (Phenix CID) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Phenix CID implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device should be used with supplemental fixation.
Device Description
The Phenix ® Cervical Interbody Device is a cervical interbody fusion device made from PEEK Optima. It is implanted from the anterior approach. The device is provided in various geometries and is designed to fit within the outer cortex of cervical spine vertebrae. It is to be packed with autogenous bone graft to facilitate fusion. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.
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