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Annex® 2 Adjacent Level System 10-9208

by Spine Wave, Inc.

Annex® 2 Adjacent Level System 10-9208 is a Class II device made by Spine Wave, Inc., cleared under FDA 510(k) K251131 on 6 Jun 2025 and listed in FDA GUDID since 9 Jan 2026 (UDI-DI 10840642172980), 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) K251131

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 Number10840642172980 UDI-DI Date9 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK251131 Date6 Jun 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251131 decided 6 Jun 2025 Active
  • FDA GUDID UDI-DI 10840642172980 listed 9 Jan 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K251131
  2. Listed FDA GUDID 10840642172980

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Annex® 2 Adjacent Level System
Generic name
Spinal implant trial
Model / Ref / Catalog
10-9208
Primary DI / UDI-DI
10840642172980
510(k) Number
FDA product code
NKB
GMDN term
Spinal implant trial
Device class
Class II
Regulation number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K251131)

and 8 more cleared under K251131

Other devices from Spine Wave, Inc.

See all devices from Spine Wave, Inc. →

Properties

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