Identity
- Trade Name
- PRESTIGE® Cervical Disc System FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- TRIAL 6972247 IMPLANT TRIAL 7X14 FDA UDI
- Model / Reference
- 6972247 FDA UDI
- Description
- TRIAL 6972247 IMPLANT TRIAL 7X14 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994237033 FDA UDI
- PMA Number
- P060018 FDA UDI
- FDA Product Code
- MJO FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class III 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
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Depth — 14.0 Millimeter FDA UDIHeight — 7.0 Millimeter FDA UDI
Category: General internal orthopaedic fixation system implantation kit
PRESTIGE® 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 General internal orthopaedic fixation system implantation kit.
- Matrixx System — NEXXT SPINE LLC · Class I
- Swedge Pedicle Screw Fixation System — SPINAL RESOURCES INC · Class II
- tangis — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ACUMED — ACUMED LLC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ALEUTIAN® Interbody Systems — K2M, INC. · Class II
- HONOUR™ Spacer System — NEXXT SPINE LLC · Class II
Cleared under the same submission
P060018 also covers:
- PRESTIGE® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE® Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE® 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 8a59aa5b-1577-42c8-b04e-2759d81dbb04 36 fields · synced May 30, 2026