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Zavation Trial 8718-812

by Zavation

Zavation Trial 8718-812 is a Class II device made by Zavation, cleared under FDA 510(k) K162496 on 4 May 2017 and listed in FDA GUDID since 14 May 2026 (UDI-DI 00197157077983), 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) K162496

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 Number00197157077983 UDI-DI Date14 May 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162496 Date4 May 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162496 decided 4 May 2017 Active
  • FDA GUDID UDI-DI 00197157077983 listed 14 May 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K162496
  2. Listed FDA GUDID 00197157077983

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Zavation Trial
Generic name
Internal spinal fixation force sensor trial
Model / reference
8718-812
Primary DI / UDI-DI
00197157077983
510(k) Number
FDA product code
MAX
GMDN term
Internal spinal fixation force sensor trial
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K162496)

and 8 more cleared under K162496

Similar devices

Other devices filed under FDA product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).

Other devices from Zavation

See all devices from Zavation →

Properties

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