INTEGRATE-C Inserter Handle DS
by Happe Spine
INTEGRATE-C Inserter Handle DS (H00000032) is a Class I device made by Happe Spine, cleared under FDA 510(k) K222004 on 28 Apr 2023 and listed in FDA GUDID since 21 Oct 2026 (UDI-DI G2308H1CH000320), active as of 2 Nov 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 | NumberG2308H1CH000320 | Date21 Oct 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222004 | Date28 Apr 2023 | StatusActive |
Official records
- FDA 510(k) database K222004
Across registries
- FDA 510(k) K222004 decided 28 Apr 2023 Active
- FDA GUDID UDI-DI G2308H1CH000320 listed 21 Oct 2026 Listed
Timeline
- Cleared FDA 510(k) K222004
- Listed FDA GUDID G2308H1CH000320
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Integrate-C
- Generic name
- Internal spinal fixation procedure kit, reusable
- Model / Ref / Catalog
- Inserter Handle DS, H00000032
- Primary DI / UDI-DI
- G2308H1CH000320
- 510(k) Number
- FDA product code
- LYQ
- GMDN term
- Internal spinal fixation procedure kit, reusable
- Device class
- Class I
- Regulation number
- 888.4540
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization