Identity
- Trade Name
- Mont Blanc MIS Spinal Systems FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Cannulated tap, dual lead Ø5 FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Cannulated tap, dual lead Ø5 FDA UDI
Identifiers
- Catalog Number
- 471TC5DL1 FDA UDI
- Primary DI / UDI-DI
- 03663422606174 FDA UDI
- 510(k) Number
- K161387 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5 Millimeter FDA UDI
Category: Orthopaedic surgical procedure kit, non-medicated, reusable
Mont Blanc MIS Spinal Systems by Spineway SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.
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- ORTHOPEDIC MANUAL SURGICAL INSTRUMENT — FX SOLUTIONS · Class I
Cleared under the same submission
K161387 also covers:
- Mont Blanc Evo Systems — Spineway SA
- Mont Blanc Evo Systems — Spineway SA
- Mont Blanc Evo Systems — Spineway SA
- Mont Blanc Evo Systems — Spineway SA
- Mont Blanc Evo Systems — Spineway SA
- Mont Blanc Evo Systems — Spineway SA
- Mont Blanc Evo Systems — Spineway SA
- Mont Blanc Evo Systems — Spineway SA
- Mont Blanc Evo Systems — Spineway SA
- Mont Blanc MIS Spinal Systems — Spineway SA
- Mont Blanc MIS Spinal Systems — Spineway SA
- Mont Blanc MIS Spinal Systems — Spineway SA
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 I | Pending data |
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Manufacturer
- Manufacturer
- Spineway SA
Sources (1)
- FDA UDI 923bbc5f-09a1-4ae8-90c6-a6636af00c18 37 fields · synced May 31, 2026