Lumbar IBFD 28L x 10W x 8H Curved, HA

Lumbar IBFD 28L x 10W x 8H Curved, HA (KTC2-281008) is a Class II device made by Keos, cleared under FDA 510(k) K193174 on 16 Dec 2019 (2 earlier submissions) and listed in FDA GUDID since 22 Feb 2018 (UDI-DI B084KTC22810080), 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

+2 more

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK193174	Date16 Dec 2019Decided	StatusActive
United States	GUDID listing	NumberB084KTC22810080 UDI-DI	Date22 Feb 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK163386	Date10 Apr 2017Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK160631	Date15 Jul 2016Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K193174
FDA 510(k) database 510(k) number K163386
FDA 510(k) database 510(k) number K160631

Across registries

2 registries list this device

FDA 510(k) K193174 decided 16 Dec 2019 Active· +2 more in the status table
FDA GUDID UDI-DI B084KTC22810080 listed 22 Feb 2018 Listed

Timeline

4 dated events

15 Jul 2016 Cleared FDA 510(k) K160631
10 Apr 2017 Cleared FDA 510(k) K163386
22 Feb 2018 Listed FDA GUDID B084KTC22810080
16 Dec 2019 Cleared FDA 510(k) K193174

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Lumbar IBFD
Generic name: Polymeric spinal interbody fusion cage
Model / Ref / Catalog: 28L x 10W x 8H Curved, HA, KTC2-281008

Primary DI / UDI-DI: B084KTC22810080
510(k) Number: K160631
K163386
K193174
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

Other devices from Keos

Keos Lumbar Instrument Rotating Distractor, QC, 6mm

Class I
Keos Lumbar Instrument

Class I
Lumbar IBFD 28L x 10W x 8H Straight, HA

Class II
Keos Lumbar Case/Caddy

Class I

See all devices from Keos →

Properties

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

Other properties (9, all answered No)