Revere 1041.1095

by Globus Medical, 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 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00889095001921 UDI-DI	Date27 Oct 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESU from GUDID Traditional	NumberK113395	Date14 Jun 2012Decided	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Revere
Generic name: Trans-facet-screw internal spinal fixation system, sterile
Model / reference: 1041.1095

Primary DI / UDI-DI: 00889095001921
510(k) Number: K113395
FDA product code: MNH, OSH, KWQ, MNI, NKB, KWP
GMDN term: Trans-facet-screw internal spinal fixation system, sterile

Device class: Class II
Regulation number: 888.3070, 888.3060, 888.3050
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Size: Length — 95 Millimeter
Outer Diameter — 4.5 Millimeter

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Properties

Sterilise before use
Single use
Lot / batch number

Other properties (12)

Supplied sterile: No
Implantable: No
Contains latex: No
Prescription use: 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