Identity
- Trade Name
- BRYAN® Cervical Disc System FDA UDI
- Generic Name
- Cervical orthopaedic reamer FDA UDI
- Device Name
- CUTTER 6474525 15MM FDA UDI
- Model / Reference
- 6474525 FDA UDI
- Description
- CUTTER 6474525 15MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994363817 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.
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC. · Class III
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC. · Class III
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC. · Class III
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC. · Class III
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC. · Class III
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC. · Class III
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC. · Class III
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC. · Class III
Cleared under the same submission
P060023 also covers:
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- BRYAN® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
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 III | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 9b2f64cf-07bd-46a2-b5bc-cca9dce8bb4d 36 fields · synced May 30, 2026