Search Results
Found 2 results
510(k) Data Aggregation
K Number
K220902Device Name
Navagio Lumbar Cage
Manufacturer
Kalitec Medical, LLC
Date Cleared
2022-05-27
(60 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
Kalitec Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Navagio Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
Navagio Lumbar Cage implants are to be used with autogenous bone graft and implanted via a transforaminal approach, or an open posterior or lateral approach. The Navagio Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Device Description
The Navagio Lumbar Cage was developed as an implant for the stabilization of the lumbar spinal column. The Navagio implants have ridges on both their inferior and superior surfaces to prevent migration, and graft windows to receive bone graft, which helps facilitate bony integration. X-ray markers are integrated for visualization of the implants after surgery. The components are available in a variety of sizes to more closely match the patient's anatomy.
Materials:
Zeniva® ZA-500 PEEK conforming to ASTM F2026. Unalloyed tantalum (ASTM F560)
Ask a Question
K Number
K182210Device Name
TiWAVE-L Porous Titanium Lumbar Cage
Manufacturer
Kalitec Medical, LLC
Date Cleared
2019-01-07
(145 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
Kalitec Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TiWAVE-L™ Porous Titanium Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). TiWAVE-L Porous Titanium Lumbar Cage implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft implanted via a transforaminal approach or an open posterior approach. The TiWAVE-L Porous Titanium Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device
Device Description
The TiWAVE-L Porous Titanium Lumbar Cages are lumbar intervertebral body fusion devices made from additive manufactured (AM) Titanium Grade 23 per ASTM F3001. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile.
Ask a Question
Page 1 of 1