Identity
- Trade Name
- PRESTIGE LP™ FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- GUIDE 6972545 CUTTER FDA UDI
- Model / Reference
- 6972545 FDA UDI
- Description
- GUIDE 6972545 CUTTER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994490322 FDA UDI
- PMA Number
- P090029 FDA UDI
- FDA Product Code
- MJO FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable 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
- Height — 5.0 Millimeter FDA UDIDepth — 14.0 Millimeter FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
Prestige Lp™ by Medtronic Sofamor Danek, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.
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Cleared under the same submission
P090029 also covers:
- PRESTIGE LP™ — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE LP™ — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE LP™ — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE LP™ — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE LP™ — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE LP™ — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE LP™ — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE LP™ — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE® LP Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE® LP Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE® LP Cervical Disc System — MEDTRONIC SOFAMOR DANEK, INC.
- PRESTIGE® LP 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 0de5e86e-1fd8-4a1e-8807-a2cb773412ab 36 fields · synced Jun 8, 2026