Aurora Spine ECHO

by Aurora Spine, Inc. 189 variants

Aurora Spine ECHO (108-32608-112) is a Class II device made by Aurora Spine, Inc., cleared under FDA 510(k) K133967 on 31 Jan 2014 and listed in FDA GUDID since 30 Apr 2019 (UDI-DI B521108326081120), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB521108326081120 UDI-DI	Date30 Apr 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK133967	Date31 Jan 2014Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K133967

Across registries

2 registries list this device

FDA 510(k) K133967 decided 31 Jan 2014 Active
FDA GUDID UDI-DI B521108326081120 listed 30 Apr 2019 Listed

Timeline

2 dated events

31 Jan 2014 Cleared FDA 510(k) K133967
30 Apr 2019 Listed FDA GUDID B521108326081120

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Aurora Spine
Generic name: Polymeric spinal fusion cage, sterile
Model / Ref / Catalog: ECHO, 108-32608-112

Primary DI / UDI-DI: B521108326081120
510(k) Number: K133967
FDA product code: MAX
GMDN term: Polymeric spinal fusion cage, sterile

Device class: Class II
Regulation number: 888.3080
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Size: Angle — 4 degree
Height — 12 Millimeter
Width — 8 Millimeter
Length — 26 Millimeter

Other devices from Aurora Spine, Inc.

See all devices from Aurora Spine, Inc. →

Properties

Sterilise before use
Prescription use
Lot / batch number

Other properties (12, all answered No)