Identity
- Trade Name
- OSCAR 3 FDA UDI
- Generic Name
- Hard/soft-tissue ultrasonic surgical system FDA UDI
- Device Name
- SINGLE USE 6MM SERRATED OSTEOTOME – STERILE FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- SINGLE USE 6MM SERRATED OSTEOTOME – STERILE FDA UDI
Identifiers
- Catalog Number
- OHSO2060SU FDA UDI
- Primary DI / UDI-DI
- 18056099649858 FDA UDI
- 510(k) Number
- K093805 FDA UDI
- FDA Product Code
- LZV FDA UDIJDX FDA UDI
- GMDN Term
- Hard/soft-tissue ultrasonic surgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.4580 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 6 Millimeter FDA UDI
Category: Hard/soft-tissue ultrasonic surgical system
Oscar 3 by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K093805 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 II | Pending data |
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Manufacturer
- Manufacturer
- Orthofix, Inc.
Sources (1)
- FDA UDI 274fd8e9-2b9c-47e1-af1c-496e04a8ff92 37 fields · synced Jun 8, 2026