← Back to catalogue

CORNERSTONE® PSR Cervical Fusion System

FDA UDI

Class II (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name
CORNERSTONE® PSR Cervical Fusion System FDA UDI
Generic Name
Spinal implant trial FDA UDI
Device Name
INSTRUMENT 6273544 DUAL TRL 14X14 4 DGRE FDA UDI
Model / Reference
6273544 FDA UDI
Description
INSTRUMENT 6273544 DUAL TRL 14X14 4 DGRE FDA UDI

Identifiers

Primary DI / UDI-DI
00613994158055 FDA UDI
510(k) Number
K111264 FDA UDI
FDA Product Code
MQP FDA UDI
ODP FDA UDI
GMDN Term
Spinal implant trial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 FDA UDI
888.3080 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Category: Spinal implant trial

CORNERSTONE® PSR Cervical Fusion System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal implant trial.

Cleared under the same submission

K111264 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Medtronic Sofamor Danek, Inc.

Sources (1)

  • FDA UDI 5c2f32d3-3458-4214-886f-f63198f9e5a3 35 fields · synced Jun 8, 2026