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TRIALTIS Spine System

FDA UDI

Class II (US FDA UDI)

by Depuy Spine, Inc.

Identity

Trade Name
TRIALTIS Spine System FDA UDI
Generic Name
Bone-screw internal spinal fixation system connector FDA UDI
Device Name
Double Side by Side Connector, 13mm FDA UDI
Model / Reference
5560-78-2553 FDA UDI
Description
Double Side by Side Connector, 13mm FDA UDI

Identifiers

Catalog Number
5560782553 FDA UDI
Primary DI / UDI-DI
10705034645766 FDA UDI
510(k) Number
K242042 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system connector FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
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

Category: Bone-screw internal spinal fixation system connector

TRIALTIS Spine System by Depuy Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system connector.

Cleared under the same submission

K242042 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Depuy Spine, Inc.

Sources (1)

  • FDA UDI e63241c1-2cbd-4f8a-8953-ce2a5769284d 36 fields · synced May 30, 2026