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# Zavation 510(k) for Ti3Z Interbody System Cleared
- URL: https://www.fdaweb.com/zavation-510-k-for-ti3z-interbody-system-cleared/
- Published: 2019-06-05T12:00:00.000Z
- Updated: 2026-09-15T01:30:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144268

FDA has approved a Zavation 510(k) to market the Ti3Z Interbody System, a lumbar intervertebral body fusion device. The device is indicated for spinal fusion procedures and used with autogenous bone graft in skeletally mature patients. The implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for treating degenerative disc disease with up to Grade 1 spondylolisthesis. It is also intended to be used with supplemental internal fixation appropriate for the implanted level, including the Zavation Pedicle Screw System.