Identity
- Trade Name
- neXus FDA UDI
- Generic Name
- Hard-tissue ultrasonic surgical system handpiece tip FDA UDI
- Device Name
- neXus BoneScalpel® Micro Hook MIS Shaver & Tubeset FDA UDI
- Model / Reference
- 110-31-2210 FDA UDI
- Description
- neXus BoneScalpel® Micro Hook MIS Shaver & Tubeset FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841626103047 FDA UDI
- 510(k) Number
- K190160 FDA UDI
- FDA Product Code
- LFL FDA UDI
- GMDN Term
- Hard-tissue ultrasonic surgical system handpiece tip FDA UDI
Classification
- Device Class
- U 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hard-tissue ultrasonic surgical system handpiece tip
neXus by Misonix, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Ultra-Drive® Tool — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K190160 also covers:
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 U | Pending data |
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Manufacturer
- Manufacturer
- Misonix, LLC
Sources (1)
- FDA UDI 733be01d-c7e4-48f6-bfc7-db25c910b537 34 fields · synced Jun 9, 2026