Ti3Z Cervical Interbody System
FDA 510(k) K191354 · Zavation Medical Products, LLC
510(k) numberK191354
Submission
- Device name
- Ti3Z Cervical Interbody System
- Applicant
- Zavation Medical Products, LLC
Flowood, MS, US - Received
- May 21, 2019
- Decision date
- September 9, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODP – Intervertebral Fusion Device With Bone Graft, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code ODP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion SystemODP · Special | Wenzel Spine, Inc. | 08/26/2026SE |
| K262489 | BluEX Cervical Expandable Cage SystemODP · Special | L&K BIOMED Co., Ltd. | 08/18/2026SE |
| K253041 | 3d Cage CervicalODP · Traditional | Fims Co., Ltd. | 07/23/2026SE |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special | Stryker Spine | 07/17/2026SE |
| K254130 | C.A. Medical Interbody Fusion SystemODP · Special | C.A. Medical, LLC | 07/08/2026SE |
| K260840 | BluEX Cervical Expandable Cage SystemODP · Traditional | L&K BIOMED Co., Ltd. | 05/16/2026SE |
| K260850 | Osteomni Spinal Cages SystemODP · Traditional | Osteomni, Inc. | 05/12/2026SE |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special | Zsfab, Inc. | 04/24/2026SE |
| K253260 | ORIO-3D Cage SystemODP · Traditional | SpineCraft | 04/16/2026SE |
| K260340 | HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional | HC Biologics, LLC | 04/13/2026SE |
More from HC Biologics, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K253943 | Tiger 2 SystemNKB · Traditional | 07/24/2026SE |
| K243908 | Tiger 2 SystemNKB · Traditional | 02/03/2025SE |
| K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…MAX · Traditional | 04/10/2024SE |
| K231811 | Zavation Connector SystemNKB · Traditional | 08/22/2023SE |
| K223808 | Zavation Navigation Instrument SystemOLO · Traditional | 07/12/2023SE |
| K230731 | Zavation ALIF SystemOVD · Traditional | 06/14/2023SE |
| 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 Cervical Interbody System cleared by the FDA?
Ti3Z Cervical Interbody System (K191354) received a 510(k) decision of Substantially Equivalent on September 9, 2019, 111 days after the submission was received.
What is the product code of K191354?
The FDA product code is ODP – Intervertebral Fusion Device With Bone Graft, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.