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Creo

FDA UDI

Class II (US FDA UDI)

by Globus Medical, Inc.

Identity

Trade Name
CREO FDA UDI
Generic Name
Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Device Name
CREO® Side Loading Monoaxial Locking Sleeve FDA UDI
Model / Reference
1148.0000 FDA UDI
Description
CREO® Side Loading Monoaxial Locking Sleeve FDA UDI

Identifiers

Primary DI / UDI-DI
00889095495188 FDA UDI
510(k) Number
K180210 FDA UDI
FDA Product Code
KWP FDA UDI
NKB FDA UDI
KWQ FDA UDI
GMDN Term
Trans-facet-screw internal spinal fixation system, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3050 FDA UDI
888.3070 FDA UDI
888.3060 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

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

Creo 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

K180210 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 e5674877-c134-4c63-84c3-163542b261b2 35 fields · synced May 30, 2026