Skip to content

Aurora Spine 119-302-3626

by Aurora Spine, Inc.

Aurora Spine 119-302-3626 is a Class I device made by Aurora Spine, Inc., cleared under FDA 510(k) K220610 on 27 May 2022 and listed in FDA GUDID since 5 Nov 2025 (UDI-DI B52111930236260), 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) K220610

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 NumberB52111930236260 UDI-DI Date5 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK220610 Date27 May 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220610 decided 27 May 2022 Active
  • FDA GUDID UDI-DI B52111930236260 listed 5 Nov 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220610
  2. Listed FDA GUDID B52111930236260

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aurora Spine
Generic name
Surgical implant/trial-implant/sizer holder, reusable
Model / reference
119-302-3626
Primary DI / UDI-DI
B52111930236260
510(k) Number
FDA product code
LXH
GMDN term
Surgical implant/trial-implant/sizer holder, reusable
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Nitrogen Dioxide

Related devices

Cleared under the same submission (K220610)

and 8 more cleared under K220610

Other devices from Aurora Spine, Inc.

See all devices from Aurora Spine, Inc. →

Properties

  • Sterilise before use
  • Lot / batch number
Other properties (13, all answered No)