Oscar 3 1
Oscar 3 1 (CH300) is a Class II device made by Orthofix, Inc., cleared under FDA 510(k) K093805 on 19 Feb 2010 and listed in FDA GUDID since 18 Sep 2017 (UDI-DI 18053504360001), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number18053504360001 | Date18 Sep 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK093805 | Date19 Feb 2010 | StatusActive |
Official records
- AccessGUDID record 18053504360001
- FDA 510(k) database K093805
Across registries
- FDA 510(k) K093805 decided 19 Feb 2010 Active
- FDA GUDID UDI-DI 18053504360001 listed 18 Sep 2017 Listed
Timeline
- Cleared FDA 510(k) K093805
- Listed FDA GUDID 18053504360001
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Oscar 3
- Generic name
- Hard/soft-tissue ultrasonic surgical system
- Model / Ref / Catalog
- 1, CH300
- Primary DI / UDI-DI
- 18053504360001
- 510(k) Number
- FDA product code
- LZV, JDX
- GMDN term
- Hard/soft-tissue ultrasonic surgical system
- Device class
- Class II
- Regulation number
- 888.4580
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Hard/soft-tissue ultrasonic surgical system.