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510(k) Data Aggregation
K Number
K202380Device Name
Born PT-LIF Cage HA
Manufacturer
Date Cleared
2021-02-19
(183 days)
Product Code
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
SpineworxX AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Born PT-LIF Cage HA is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels of the spine from L2 to S1. These DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted in open surgery via a posterior or transforaminal approach. These devices are intended to be used with supplemental fixation which has been cleared for use in the lumbosacral spine.
Device Description
The Born PT-LIF Cage HA is an interbody fusion device which is inserted between two lumbar or lumbosacral vertebral bodies to replace a collapsed, damaged, or unstable disc. The cage is manufactured from PEEK-OPTIMA™ HA Enhanced. The cage contains a hollow center to allow for bone graft packing, and radiopaque positioning markers. The cage is designed with a bullet nose for easier insertion and serrated contact surfaces for fixation and stability. The device is available in different lengths (25, 28, 32, 36mm), heights (7-17mm in 1mm increments), and degrees of lordosis (0, 4, 8, 12, 16°). All cages are 10mm wide. The Born PT-LIF Cage HA shall be used with autogenous bone graft and supplemental fixation. The cages are single use devices, which are sterilized via gamma radiation and provided to the user in sterile packages. The instruments used to insert the cage are manufactured from medical grade stainless steel and must be sterilized prior to use.
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