Libra Pedicle Screw System LP4550
Libra Pedicle Screw System LP4550 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 00841327102790), 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 | Number00841327102790 | Date27 May 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151770 | Date20 Nov 2015 | StatusActive |
Official records
- AccessGUDID record 00841327102790
- FDA 510(k) database K151770
Across registries
- FDA 510(k) K151770 decided 20 Nov 2015 Active
- FDA GUDID UDI-DI 00841327102790 listed 27 May 2016 Listed
Timeline
- Cleared FDA 510(k) K151770
- Listed FDA GUDID 00841327102790
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- Withdrawn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
- LP4550
- Primary DI / UDI-DI
- 00841327102790
- 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 — 4.5 MillimeterLength — 50 Millimeter
Similar devices
Other devices filed under FDA product code MNH (Orthosis, Spondylolisthesis Spinal Fixation).
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- Erisma™-LP 18018550 by Clariance, Inc.
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- ROMEO Posterior Osteosynthesis System ELL-RD 40 45-S by Spineart
- Tyche Pedicle Screw System by Kyung Won Medical Co., Ltd.
- MESA Spinal System by K2M, INC.
- Simmons Plating System Bolt and Screw by Smith & Nephew, Inc.
- EXPEDIUM 179792020 by MEDOS INTERNATIONAL SARL