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Merete® CS Cortical Screw Fully Threaded

FDA UDI

Class II (US FDA UDI)

by Merete GmbH

Identity

Trade Name
Merete® CS Cortical Screw Fully Threaded FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
TiAl6V4 ELI sterile FDA UDI
Model / Reference
3.0 26 T10 FDA UDI
Description
TiAl6V4 ELI sterile FDA UDI

Identifiers

Catalog Number
CR30326S FDA UDI
Primary DI / UDI-DI
04048266145819 FDA UDI
510(k) Number
K152187 FDA UDI
FDA Product Code
HRS FDA UDI
HWC FDA UDI
GMDN Term
Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
888.3040 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 26 Millimeter FDA UDI
Outer Diameter — 3.0 Millimeter FDA UDI

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

Cleared under the same submission

K152187 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 42d5a06d-5a8a-4876-9cd8-f7a6acec047c 38 fields · synced Jun 1, 2026