Expedium

FDA UDI

Class II (US FDA UDI)

by Depuy Spine, Inc.

Identity

Trade Name: EXPEDIUM FDA UDI
Generic Name: Spinal bone set screw FDA UDI
Device Name: EXPEDIUM SPINE SYSTEM DOMED NUT 4.5 FDA UDI
Model / Reference: 186100002 FDA UDI
Description: EXPEDIUM SPINE SYSTEM DOMED NUT 4.5 FDA UDI

Identifiers

Catalog Number: 186100002 FDA UDI
Primary DI / UDI-DI: 10705034103853 FDA UDI
510(k) Number: K081252 FDA UDI
K111136 FDA UDI
FDA Product Code: MNH FDA UDI
KWP FDA UDI
KWQ FDA UDI
OSH FDA UDI
MNI FDA UDI
NKB FDA UDI
GMDN Term: Spinal bone set screw FDA UDI

Classification

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

Yes

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

Category: Spinal bone set screw

Expedium by Depuy Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K081252 also covers:

K111136 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: Depuy Spine, Inc.

Sources (1)

FDA UDI 1806099d-374c-4d23-9a5b-463df1709579 36 fields · synced Jun 8, 2026