Ballast 02-1000-000
Ballast 02-1000-000 is a Class II device made by Isotis Orthobiologics, Inc, cleared under FDA 510(k) K200290 on 11 May 2020 and listed in FDA GUDID since 30 Jul 2020 (UDI-DI 10889981232122), 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 | Number10889981232122 | Date30 Jul 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK200290 | Date11 May 2020 | StatusActive |
Official records
- AccessGUDID record 10889981232122
- FDA 510(k) database K200290
Across registries
- FDA 510(k) K200290 decided 11 May 2020 Active
- FDA GUDID UDI-DI 10889981232122 listed 30 Jul 2020 Listed
Timeline
- Cleared FDA 510(k) K200290
- Listed FDA GUDID 10889981232122
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ballast
- Generic name
- Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
- Model / Ref / Catalog
- 02-1000-000
- Primary DI / UDI-DI
- 10889981232122
- 510(k) Number
- FDA product code
- MQV
- GMDN term
- Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3045
- GUDID distribution status
- In Commercial Distribution
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