Pillar Tl 45-7408

by Orthofix US LLC

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	Number18257200039920 UDI-DI	Date19 Mar 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK060350	Date24 Feb 2006Decided	StatusActive

Official records

AccessGUDID record UDI-DI 18257200039920
FDA 510(k) database 510(k) number K060350

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Withdrawn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: Pillar Tl
Generic name: Metallic spinal interbody fusion cage
Model / reference: 45-7408

Primary DI / UDI-DI: 18257200039920
510(k) Number: K060350
FDA product code: MQP
GMDN term: Metallic spinal interbody fusion cage

Device class: Class II
Regulation number: 888.3060
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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See all devices from Orthofix US LLC →

Properties

Sterilise before use
Implantable
Prescription use
Lot / batch number

Other properties (11)

Supplied sterile: No
Single use: 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