VERTACONNECT Inserter
by SIGNUS Medizintechnik GmbH 2 variants
VERTACONNECT Inserter (CAT4001) is a Class II device made by SIGNUS Medizintechnik GmbH, cleared under FDA 510(k) K203327 on 25 Jan 2021 and listed in FDA GUDID since 25 Jan 2023 (UDI-DI 04047844100905), active as of 22 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 | Number04047844100905 | Date25 Jan 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK203327 | Date25 Jan 2021 | StatusActive |
Official records
- AccessGUDID record 04047844100905
- FDA 510(k) database K203327
Across registries
- FDA 510(k) K203327 decided 25 Jan 2021 Active
- FDA GUDID UDI-DI 04047844100905 listed 25 Jan 2023 Listed
Timeline
- Cleared FDA 510(k) K203327
- Listed FDA GUDID 04047844100905
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vertaconnect
- Generic name
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Model / Ref / Catalog
- Inserter, CAT4001
- Primary DI / UDI-DI
- 04047844100905
- 510(k) Number
- FDA product code
- MAX
- GMDN term
- Orthopaedic surgical procedure kit, non-medicated, 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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