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Merete® CS Cortical Screw Partly Threaded

FDA UDI

Class II (US FDA UDI)

by Merete GmbH

Identity

Trade Name
Merete® CS Cortical Screw Partly Threaded FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
TiAl6V4 ELI non-sterile FDA UDI
Model / Reference
3.5 28 FDA UDI
Description
TiAl6V4 ELI non-sterile FDA UDI

Identifiers

Catalog Number
CR35228 FDA UDI
Primary DI / UDI-DI
04048266135049 FDA UDI
510(k) Number
K130400 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 28 Millimeter FDA UDI
Outer Diameter — 3.5 Millimeter FDA UDI

Merete® CS Cortical Screw Partly Threaded by Merete GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K130400 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merete GmbH

Sources (1)

  • FDA UDI 6eebffc7-8cda-4fe2-aa4b-1ed3ab68a015 38 fields · synced May 31, 2026