Ti3Z Lumbar Interbody System
FDA 510(k) K212811 · Zavation Medical Products, LLC
510(k) numberK212811
Submission
- Device name
- Ti3Z Lumbar Interbody System
- Applicant
- Zavation Medical Products, LLC
Flowood, MS, US - Received
- September 3, 2021
- Decision date
- April 12, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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| K223808 | Zavation Navigation Instrument SystemOLO · Traditional | 07/12/2023SE |
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| K221726 | Uni-FuZe-C Bone StripMQV · Traditional | 01/18/2023SE |
| K222614 | Zavation Spinal SystemNKB · Traditional | 12/05/2022SE |
| K221049 | Zavation VariSync Plate System and VariSync Spacer SystemOVE · Traditional | 08/12/2022SE |
| K220581 | Zavation eZspand Interbody SystemMAX · Traditional | 06/02/2022SE |
Questions and answers
When was Ti3Z Lumbar Interbody System cleared by the FDA?
Ti3Z Lumbar Interbody System (K212811) received a 510(k) decision of Substantially Equivalent on April 12, 2022, 221 days after the submission was received.
What is the product code of K212811?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.