Zavation VariSync Plate System and VariSync Spacer System
FDA 510(k) K221049 · Zavation Medical Products, LLC
510(k) numberK221049
Submission
- Device name
- Zavation VariSync Plate System and VariSync Spacer System
- Applicant
- Zavation Medical Products, LLC
Flowood, MS, US - Received
- April 11, 2022
- Decision date
- August 12, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVE – Intervertebral Fusion Device With Integrated Fixation, 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 with or without supplemental fixation.
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| K260036 | NeckTune 3D SA Cervical CageOVE · Traditional | Medyssey Co, Ltd. | 06/15/2026SE |
| K260660 | SABER-C SystemOVE · Traditional | Elevation Spine | 04/27/2026SE |
| K253213 | SAGI Cervical Cage SystemOVE · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 04/20/2026SE |
| K252774 | Uni-C Cervical Cage SystemOVE · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 04/15/2026SE |
| K260038 | E3D-C Interbody SystemOVE · Special | Evolution Spine | 02/04/2026SE |
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| K221726 | Uni-FuZe-C Bone StripMQV · Traditional | 01/18/2023SE |
| K222614 | Zavation Spinal SystemNKB · Traditional | 12/05/2022SE |
| K220581 | Zavation eZspand Interbody SystemMAX · Traditional | 06/02/2022SE |
| K212811 | Ti3Z Lumbar Interbody SystemMAX · Traditional | 04/12/2022SE |
Questions and answers
When was Zavation VariSync Plate System and VariSync Spacer System cleared by the FDA?
Zavation VariSync Plate System and VariSync Spacer System (K221049) received a 510(k) decision of Substantially Equivalent on August 12, 2022, 123 days after the submission was received.
What is the product code of K221049?
The FDA product code is OVE – Intervertebral Fusion Device With Integrated Fixation, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.