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510(k) Data Aggregation
K Number
K221858Device Name
ZSFab Lumbar Interbody System
Manufacturer
ZS Fab Inc.
Date Cleared
2022-10-14
(109 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
ZS Fab Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ZSFab Lumbar Interbody System is intended for lumbar interbody fusion. The devices are indicated for use at one or two contiguous levels in the lumbar spine from L2-S1, in skeletally mature patients who have had at least six months of non-operative treatment. The ZSFab Lumbar Interbody System is indicated to treat lumbar degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by imaging studies (radiographs, CT, MRI). Additionally, the ZSFab Lumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The ZSFab lumbar Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion and to be used with supplemental fixation cleared for use in the lumbosacral spine.
Device Description
The ZSFab Lumbar Interbody System includes additively manufactured interbody fusion devices for lumbar implantation. The implants are designed as a solid frame that includes lattice structures to provide surgical stabilization of the spine. The lattices have near-elliptical pores with axis lengths of 610-1000µm. The endplates are featured with teeth design and stochastic lattice structures with average pore size of 620-710µm. Each lumbar interbody has a central cavity for bone graft material. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances. The implants are sold sterile.
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