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Zavation Vbr Trial 02C02446

by Zavation

Zavation Vbr Trial 02C02446 is a Class II device made by Zavation, cleared under FDA 510(k) K202637 on 23 Dec 2020 and listed in FDA GUDID since 30 Apr 2026 (UDI-DI 00197157054045), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K202637

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00197157054045 UDI-DI Date30 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK202637 Date23 Dec 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K202637 decided 23 Dec 2020 Active
  • FDA GUDID UDI-DI 00197157054045 listed 30 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K202637
  2. Listed FDA GUDID 00197157054045

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Zavation Vbr Trial
Generic name
Internal spinal fixation force sensor trial
Model / reference
02C02446
Primary DI / UDI-DI
00197157054045
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

Related devices

Cleared under the same submission (K202637)

and 8 more cleared under K202637

Similar devices

Other devices filed under FDA product code MQP (Spinal Vertebral Body Replacement Device).

Other devices from Zavation

See all devices from Zavation →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)