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BRYAN® Cervical Disc System

FDA UDI

Class III (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name
BRYAN® Cervical Disc System FDA UDI
Generic Name
Cervical orthopaedic reamer FDA UDI
Device Name
DISC 6478415 MILLING 15MM FDA UDI
Model / Reference
6478415 FDA UDI
Description
DISC 6478415 MILLING 15MM FDA UDI

Identifiers

Primary DI / UDI-DI
00613994365323 FDA UDI
PMA Number
P060023 FDA UDI
FDA Product Code
MJO FDA UDI
GMDN Term
Cervical orthopaedic reamer FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Dimensions & Sizes

Size
Outer Diameter — 15.0 Millimeter FDA UDI

Category: Cervical orthopaedic reamer

BRYAN® Cervical Disc System by Medtronic Sofamor Danek, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cervical orthopaedic reamer.

Cleared under the same submission

P060023 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Sofamor Danek, Inc.

Sources (1)

  • FDA UDI f1e152ea-9816-468a-87df-4974cdf9e3f6 36 fields · synced May 30, 2026