Ascent Le 65-5320

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	Number18257200018598 UDI-DI	Date19 Mar 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK111183	Date24 May 2011Decided	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Withdrawn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: Ascent Le
Generic name: Bone-screw internal spinal fixation system, non-sterile
Model / reference: 65-5320

Primary DI / UDI-DI: 18257200018598
510(k) Number: K111183
FDA product code: KWP
GMDN term: Bone-screw internal spinal fixation system, non-sterile

Device class: Class II
Regulation number: 888.3050
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Other devices from Orthofix US LLC

Pillar SA 49-0093

Class I
Firebird Sfs 51-0070

Class I
Firebird Sfs 51-0570

Class I
Firebird Sfs, Special Products 52-1002

Class I
Proview 54-1001

Class I
Removal Instruments 54-1035

Class I

See all devices from Orthofix US LLC →

Properties

Sterilise before use
Single use
Prescription use
Lot / batch number

Other properties (11)

Supplied sterile: No
Implantable: 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