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Anthem

FDA UDI

Class II (US FDA UDI)

by Globus Medical, Inc.

Identity

Trade Name
ANTHEM FDA UDI
Generic Name
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
Device Name
MonoAx Locking Screw, 3.5 X 16mm, SS FDA UDI
Model / Reference
2179.5016 FDA UDI
Description
MonoAx Locking Screw, 3.5 X 16mm, SS FDA UDI

Identifiers

Primary DI / UDI-DI
00889095408676 FDA UDI
510(k) Number
K163361 FDA UDI
FDA Product Code
HWC FDA UDI
HRS FDA UDI
GMDN Term
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
888.3030 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
Outer Diameter — 3.5 Millimeter FDA UDI
Length — 16 Millimeter FDA UDI

Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

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

Similar devices

Also classified as Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile.

Cleared under the same submission

K163361 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 e6e5eb41-aa2c-4d63-95b7-e36f146fe359 36 fields · synced Jun 8, 2026