Modification to Easyspine System
510(k) K063794
Modification to Easyspine System is a Class II device made by Ldr Spine USA, cleared under FDA 510(k) K063794 on 24 Jan 2007, 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 | NumberK063794 | Date24 Jan 2007 | StatusActive |
Official records
- FDA 510(k) database K063794
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MNI
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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