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Cortical Screw

FDA UDI

Class II (US FDA UDI)

by I.T.S. GmbH

Identity

Trade Name
Cortical Screw FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
Cortical Screw, D=2.7mm, L=6mm FDA UDI
Model / Reference
32271-6 FDA UDI
Description
Cortical Screw, D=2.7mm, L=6mm FDA UDI

Identifiers

Catalog Number
32271-6 FDA UDI
Primary DI / UDI-DI
09120047294055 FDA UDI
510(k) Number
K033756 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Cortical Screw by I.T.S. GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K033756 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
I.T.S. GmbH

Sources (1)

  • FDA UDI e32443d1-49c2-4888-893b-50cf90ea0d60 36 fields · synced Jun 8, 2026