Plateau 2018-0017
Plateau 2018-0017 is a Class II device made by Life Spine, Inc., cleared under FDA 510(k) K130630 on 13 Jun 2013 and listed in FDA GUDID since 7 Nov 2019 (UDI-DI 00190837032289), 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 | Number00190837032289 | Date7 Nov 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK130630 | Date13 Jun 2013 | StatusActive |
Official records
- AccessGUDID record 00190837032289
- FDA 510(k) database K130630
Across registries
- FDA 510(k) K130630 decided 13 Jun 2013 Active
- FDA GUDID UDI-DI 00190837032289 listed 7 Nov 2019 Listed
Timeline
- Cleared FDA 510(k) K130630
- Listed FDA GUDID 00190837032289
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Plateau
- Generic name
- Bone file/rasp, manual, reusable
- Model / Ref / Catalog
- 2018-0017
- Primary DI / UDI-DI
- 00190837032289
- 510(k) Number
- FDA product code
- MAX
- GMDN term
- Bone file/rasp, manual, reusable
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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