Spotlight 282915081
Spotlight 282915081 is a Class II device made by Depuy Spine, Inc., cleared under FDA 510(k) K062814 on 15 Dec 2006 and listed in FDA GUDID since 30 Jun 2016 (UDI-DI 10705034206028), 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 | Number10705034206028 | Date30 Jun 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK062814 | Date15 Dec 2006 | StatusActive |
Official records
- AccessGUDID record 10705034206028
- FDA 510(k) database K062814
Across registries
- FDA 510(k) K062814 decided 15 Dec 2006 Active
- FDA GUDID UDI-DI 10705034206028 listed 30 Jun 2016 Listed
Timeline
- Cleared FDA 510(k) K062814
- Listed FDA GUDID 10705034206028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Spotlight
- Generic name
- Laparoscopic multi-instrument access port, single-use
- Model / Ref / Catalog
- 282915081
- Primary DI / UDI-DI
- 10705034206028
- 510(k) Number
- FDA product code
- GZT
- GMDN term
- Laparoscopic multi-instrument access port, single-use
- Device class
- Class II
- Regulation number
- 882.4800
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Laparoscopic multi-instrument access port, single-use.