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Monarch

FDA UDI

Class II (US FDA UDI)

by Medos International Sàrl

Identity

Trade Name
MONARCH FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
MONARCH SPINE SYSTEM POLYAXIAL SCREW 5.5 x 5.5 x 40mm FDA UDI
Model / Reference
177435540 FDA UDI
Description
MONARCH SPINE SYSTEM POLYAXIAL SCREW 5.5 x 5.5 x 40mm FDA UDI

Identifiers

Catalog Number
177435540 FDA UDI
Primary DI / UDI-DI
10705034061498 FDA UDI
510(k) Number
K024348 FDA UDI
FDA Product Code
MNI FDA UDI
MNH FDA UDI
KWP FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3050 FDA UDI
Commercial Distribution
Not 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

Yes

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

Monarch by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K024348 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medos International Sàrl

Sources (1)

  • FDA UDI 7744bec2-177f-4dd1-bf02-458d23812b7f 37 fields · synced May 31, 2026