L-Box® XLC550800

by INNO Holdings, Inc.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberM711XLC5508000 UDI-DI	Date18 Sep 2014Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK121581	Date17 Oct 2012Decided	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: L-Box®
Generic name: Polymeric spinal interbody fusion cage
Model / Ref / Catalog: XLC550800

Primary DI / UDI-DI: M711XLC5508000
FDA product code: MAX
GMDN term: Polymeric spinal interbody fusion cage

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

Sterilisation method: Moist Heat or Steam Sterilization

Size: Angle — 0 degree
Height — 8 Millimeter
Length — 55 Millimeter
Width — 22 Millimeter

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Properties

Sterilise before use
Single use
Implantable
Prescription use
Lot / batch number

Other properties (10)

Supplied sterile: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Expiration date: No
Manufacturing date: No