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centrolock®

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref SP012524

by Novastep

Identity

Trade Name
centrolock® EUDAMEDFDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
Sterile osteosynthesis screw-plate system EUDAMED
Locking screw Ø2.5 lg24 FDA UDI
Model / Reference
SP012524 EUDAMEDFDA UDI
Description
Locking screw Ø2.5 lg24 FDA UDI

Identifiers

Catalog Number
SP012524 FDA UDI
Primary DI / UDI-DI
03700879512303 EUDAMEDFDA UDI
Basic UDI-DI
370087950TF2B0802000A9 EUDAMED
FDA Product Code
HRS FDA UDI
EMDN Code
P09120503 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS EUDAMED
GMDN Term
Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

FDA UDI

Category: Orthopaedic bone screw (non-sliding)

centrolock® by Novastep — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Novastep

Sources (2)

  • FDA UDI 5d7dedad-ec14-484b-9fc5-6a3ce95a7b90 35 fields · synced Sep 30, 2026
  • EUDAMED 975b98fc-9464-4fde-a9bf-ac55dfe7ee41 61 fields · synced Sep 30, 2026