Zavation Vbr Trial 02C02402
by Zavation
Zavation Vbr Trial 02C02402 is a Class II device made by Zavation, cleared under FDA 510(k) K202637 on 23 Dec 2020 and listed in FDA GUDID since 29 Apr 2026 (UDI-DI 00197157053604), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00197157053604 | Date29 Apr 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK202637 | Date23 Dec 2020 | StatusActive |
Official records
- AccessGUDID record 00197157053604
- FDA 510(k) database K202637
Across registries
- FDA 510(k) K202637 decided 23 Dec 2020 Active
- FDA GUDID UDI-DI 00197157053604 listed 29 Apr 2026 Listed
Timeline
- Cleared FDA 510(k) K202637
- Listed FDA GUDID 00197157053604
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Zavation Vbr Trial
- Generic name
- Internal spinal fixation force sensor trial
- Model / reference
- 02C02402
- Primary DI / UDI-DI
- 00197157053604
- 510(k) Number
- FDA product code
- MQP
- GMDN term
- Internal spinal fixation force sensor trial
- Device class
- Class II
- Regulation number
- 888.3060
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices
Other devices filed under FDA product code MQP (Spinal Vertebral Body Replacement Device).
- VERTE-STACK SPINAL SYSTEM by MEDTRONIC SOFAMOR DANEK, INC.
- KONG-TL VBR System, Implant Assembly Plate 44-020 by icotec AG
- CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM by Choicespine, LP
- NuVasive(r) Monolith Corpectomy System by Nu Vasive, Incorporated
- SYNTHES VERTEBRAL SPACER TI by Synthes (Usa)
- PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER) by Pioneer Surgical Technology, Inc.
- SYNFIX-LR by Synthes Spine Co.Lp
- Ascend VBR System, Ascend NanoTec VBR System by ALPHATEC SPINE, INC.
- TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189 by Interpore Cross Intl.
- CONCORDE VBR SPINAL SYSTEM by Depuy Spine, Inc.