Libra Pedicle Screw System LROD35
Libra Pedicle Screw System LROD35 is a Class II device made by Spinal Balance, Inc., cleared under FDA 510(k) K151770 on 20 Nov 2015 and listed in FDA GUDID since 27 May 2016 (UDI-DI 00841327105685), 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 | Number00841327105685 | Date27 May 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151770 | Date20 Nov 2015 | StatusActive |
Official records
- AccessGUDID record 00841327105685
- FDA 510(k) database K151770
Across registries
- FDA 510(k) K151770 decided 20 Nov 2015 Active
- FDA GUDID UDI-DI 00841327105685 listed 27 May 2016 Listed
Timeline
- Cleared FDA 510(k) K151770
- Listed FDA GUDID 00841327105685
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Libra Pedicle Screw System
- Generic name
- Bone-screw internal spinal fixation system, sterile
- Model / reference
- LROD35
- Primary DI / UDI-DI
- 00841327105685
- 510(k) Number
- FDA product code
- MNH, MNI, NKB
- GMDN term
- Bone-screw internal spinal fixation system, sterile
- Device class
- Class II
- Regulation number
- 888.3070
- GUDID distribution status
- In Commercial Distribution
- Size
- Outer Diameter — 5.5 MillimeterLength — 35 Millimeter