Xpand 116.302
Xpand 116.302 is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K050850 on 26 May 2005 and listed in FDA GUDID since 9 Oct 2015 (UDI-DI 00849044022964), 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 | Number00849044022964 | Date9 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK050850 | Date26 May 2005 | StatusActive |
Official records
- AccessGUDID record 00849044022964
- FDA 510(k) database K050850
Across registries
- FDA 510(k) K050850 decided 26 May 2005 Active
- FDA GUDID UDI-DI 00849044022964 listed 9 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K050850
- Listed FDA GUDID 00849044022964
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Xpand
- Generic name
- Vertebral body prosthesis
- Model / reference
- 116.302
- Primary DI / UDI-DI
- 00849044022964
- 510(k) Number
- FDA product code
- MQP
- GMDN term
- Vertebral body prosthesis
- Device class
- Class II
- Regulation number
- 888.3060
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Width — 23 MillimeterDepth — 21 MillimeterHeight — 19 Millimeter
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- ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM by SIGNUS Medizintechnik GmbH