centrolock®

FDA UDI

Class II (US FDA UDI)

by Novastep

Identity

Trade Name: centrolock® FDA UDI
Generic Name: Surgical implant template, reusable FDA UDI
Device Name: 4mm trial implant Left FDA UDI
Model / Reference: XTI06014 FDA UDI
Description: 4mm trial implant Left FDA UDI

Identifiers

Catalog Number: XTI06014 FDA UDI
Primary DI / UDI-DI: 03700879511788 FDA UDI
FDA Product Code: HRS FDA UDI
GMDN Term: Surgical implant template, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical implant template, reusable

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

Similar devices

Also classified as Surgical implant template, reusable.

Newclip Instruments — NEWCLIP TECHNICS · Class I
Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class I
Legion — Smith & Nephew, Inc. · Class II
LIGAFIX® — S.B.M. SAS · Class I
EVOS — Smith & Nephew, Inc. · Class I
Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
VFT — Ldr Spine USA · Class II
Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Novastep

Sources (1)

FDA UDI 619a9ab8-0f71-4224-a2d1-84a0d60238de 35 fields · synced Jun 8, 2026