Xemplifi 8103.0208S
Xemplifi 8103.0208S is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K103036 on 10 Jan 2011 and listed in FDA GUDID since 10 Oct 2015 (UDI-DI 00889095205916), 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 | Number00889095205916 | Date10 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK103036 | Date10 Jan 2011 | StatusActive |
Official records
- AccessGUDID record 00889095205916
- FDA 510(k) database K103036
Across registries
- FDA 510(k) K103036 decided 10 Jan 2011 Active
- FDA GUDID UDI-DI 00889095205916 listed 10 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K103036
- Listed FDA GUDID 00889095205916
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Xemplifi
- Generic name
- Human-derived demineralized bone matrix implant
- Model / reference
- 8103.0208S
- Primary DI / UDI-DI
- 00889095205916
- 510(k) Number
- FDA product code
- MBP, MQV
- GMDN term
- Human-derived demineralized bone matrix implant
- Device class
- Class II
- Regulation number
- 888.3045
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 8 Milliliter
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