Universal Spinal System
by Double Medical Technology Inc.
510(k) K252729
Universal Spinal System is a Class II device made by Double Medical Technology Inc., cleared under FDA 510(k) K252729 on 18 Nov 2025, 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 | NumberK252729 | Date18 Nov 2025 | StatusActive |
Official records
- FDA 510(k) database K252729
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NKB
- FDA applicant
- Double Medical Technology, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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