Integrate-C
Integrate-C (R1112M07) 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 25 Aug 2023 (UDI-DI G2308H1CR012M70), 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 | NumberG2308H1CR012M70 | Date25 Aug 2023 | 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 G2308H1CR012M70 listed 25 Aug 2023 Listed
Timeline
- Cleared FDA 510(k) K222004
- Listed FDA GUDID G2308H1CR012M70
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Internal spinal fixation procedure kit, reusable
- Model / Ref / Catalog
- Rasping Trial - Medium 17 x 14 x 11/12 mm, 7 deg, R1112M07
- Primary DI / UDI-DI
- G2308H1CR012M70
- 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