Libra Pedicle Screw System CO300
Libra Pedicle Screw System CO300 is a Class II device made by Spinal Balance, Inc., listed in FDA GUDID since 10 Nov 2016 (UDI-DI 00841327107610), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00841327107610 | Date10 Nov 2016 | StatusListed |
Official records
- AccessGUDID record 00841327107610
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Libra Pedicle Screw System
- Generic name
- Bone-screw internal spinal fixation system, sterile
- Model / reference
- CO300
- Primary DI / UDI-DI
- 00841327107610
- FDA product code
- MNI, MNH, 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
- Length — 400 MillimeterOuter Diameter — 5.5 Millimeter
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Other devices filed under FDA product code MNI (Orthosis, Spinal Pedicle Fixation).
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