Adena-Zina Spinal System
by Shanghai Sanyou Medical Co., Ltd.
510(k) K231931
Adena-Zina Spinal System is a Class II device made by Shanghai Sanyou Medical Co., Ltd., cleared under FDA 510(k) K231931 on 28 Jul 2023, 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 | FDA 510(k)SESE | NumberK231931 | Date28 Jul 2023 | StatusActive |
Official records
- FDA 510(k) database K231931
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NKB
- FDA applicant
- Shanghai Sanyou Medical Co, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent