Providence

FDA UDI

Class II (US FDA UDI)

by Globus Medical, Inc.

Identity

Trade Name: PROVIDENCE FDA UDI
Generic Name: Spinal fixation plate, non-bioabsorbable FDA UDI
Device Name: PROVIDENCE 4.2mm Fixed Angle Screw, Self-Tapping 12mm FDA UDI
Model / Reference: 150.032 FDA UDI
Description: PROVIDENCE 4.2mm Fixed Angle Screw, Self-Tapping 12mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00849044003239 FDA UDI
510(k) Number: K070775 FDA UDI
FDA Product Code: KWQ FDA UDI
GMDN Term: Spinal fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 4.2 Millimeter FDA UDI
Length — 12 Millimeter FDA UDI

Category: Spinal fixation plate, non-bioabsorbable

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

Similar devices

Also classified as Spinal fixation plate, non-bioabsorbable.

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Cervalign — Xtant Medical Holdings, Inc. · Class II
CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc. · Class II
TSLP — Synthes · Class II
AESCULAP — AESCULAP, INC. · Class II
ACP — Nuvasive, Inc. · Class II
uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · Class II
Rexious — Dio Medical Co., Ltd. · Class II

Cleared under the same submission

K070775 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Globus Medical, Inc.

Sources (1)

FDA UDI 32e18e3e-3be6-4b7a-a492-f31a56b5a09a 36 fields · synced May 29, 2026