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Revere

FDA UDI

Class II (US FDA UDI)

by Globus Medical, Inc.

Identity

Trade Name
REVERE FDA UDI
Generic Name
Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Device Name
6.35mm SS Unit Rod, 375mm FDA UDI
Model / Reference
234.415 FDA UDI
Description
6.35mm SS Unit Rod, 375mm FDA UDI

Identifiers

Primary DI / UDI-DI
00889095193978 FDA UDI
510(k) Number
K122226 FDA UDI
FDA Product Code
KWQ FDA UDI
KWP FDA UDI
MNI FDA UDI
NKB FDA UDI
MNH FDA UDI
GMDN Term
Trans-facet-screw internal spinal fixation system, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 FDA UDI
888.3050 FDA UDI
888.3070 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 375 Millimeter FDA UDI
Outer Diameter — 6.35 Millimeter FDA UDI

Category: Trans-facet-screw internal spinal fixation system, sterile

Revere by Globus Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Trans-facet-screw internal spinal fixation system, sterile.

Cleared under the same submission

K122226 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Globus Medical, Inc.

Sources (1)

  • FDA UDI c00fd9e8-d2ac-4dde-a7b0-0c70f4eccb84 36 fields · synced Jun 1, 2026