Libra Pedicle Screw System
Libra Screw Assembly, Polyaxial, Cannulated, 6.5mm x 60mm
13manufacturers in China registered for this device type
73catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spondylolisthesis Spinal Fixation
Record
| Listed by | Spinal Balance, Inc., United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K151770 |
| Record published | 2016-05-27 |
| Record revised | 2025-07-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 4.5 to 7.5 mm; length 25 to 200 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LROD45C | Outer Diameter 5.5 mm | In distribution |
| LP5535 | Length 35 mm | In distribution |
| LP6560C | Outer Diameter 6.5 mm | In distribution |
| LROD110 | Outer Diameter 5.5 mm | In distribution |
| LP5540C | Outer Diameter 5.5 mm | In distribution |
| LROD200 | Outer Diameter 5.5 mm | In distribution |
| LP7535 | Outer Diameter 7.5 mm | In distribution |
| LP7550 | Outer Diameter 7.5 mm | In distribution |
| LP7535C | Outer Diameter 7.5 mm | In distribution |
| LP6525 | Outer Diameter 6.5 mm | In distribution |
| LP6545 | Length 45 mm | In distribution |
| LROD90 | Outer Diameter 5.5 mm | In distribution |
| LP4550 | Outer Diameter 4.5 mm | In distribution |
| LROD65C | Outer Diameter 5.5 mm | In distribution |
| LROD120C | Outer Diameter 5.5 mm | In distribution |
| LP8580 | Outer Diameter 7.5 mm | In distribution |
| LP5535C | Outer Diameter 5.5 mm | In distribution |
| LP7545C | Outer Diameter 7.5 mm | In distribution |
| LP7555 | Outer Diameter 7.5 mm | In distribution |
| LP6550C | Outer Diameter 6.5 mm | In distribution |
| LP6545C | Outer Diameter 6.5 mm | In distribution |
| LP5540 | Length 40 mm | In distribution |
| LP7550C | Outer Diameter 7.5 mm | In distribution |
| LROD55C | Outer Diameter 5.5 mm | In distribution |
| LP5560C | Outer Diameter 5.5 mm | In distribution |
| LROD90C | Outer Diameter 5.5 mm | In distribution |
| LP5530C | Outer Diameter 5.5 mm | In distribution |
| LROD35C | Outer Diameter 5.5 mm | In distribution |
| LP6535C | Outer Diameter 6.5 mm | In distribution |
| LROD150 | Outer Diameter 5.5 mm | In distribution |
| LROD115C | Outer Diameter 5.5 mm | In distribution |
| LP6540 | Length 40 mm | In distribution |
| LP7560 | Outer Diameter 7.5 mm | In distribution |
| LB-TAP-70 | Outer Diameter 7.0 mm | In distribution |
| LROD110C | Outer Diameter 5.5 mm | In distribution |
| LROD50C | Outer Diameter 5.5 mm | In distribution |
| LP8580C | Outer Diameter 7.5 mm | In distribution |
| LSETSCREW | In distribution | |
| LP7555C | Outer Diameter 7.5 mm | In distribution |
| LP4530 | Outer Diameter 4.5 mm | In distribution |
| LP5555C | Outer Diameter 5.5 mm | In distribution |
| LP4535 | Outer Diameter 4.5 mm | In distribution |
| LP7540 | Outer Diameter 7.5 mm | In distribution |
| LROD50 | Outer Diameter 5.5 mm | In distribution |
| LP7530C | Outer Diameter 7.5 mm | In distribution |
| LP7560C | Outer Diameter 7.5 mm | In distribution |
| LP7530 | Length 30 mm | In distribution |
| LP5545C | Outer Diameter 5.5 mm | In distribution |
| LROD35 | Outer Diameter 5.5 mm | In distribution |
| LROD60C | Outer Diameter 5.5 mm | In distribution |
| LP7545 | Outer Diameter 7.5 mm | In distribution |
| LROD80 | Outer Diameter 5.5 mm | In distribution |
| LP6540C | Outer Diameter 6.5 mm | In distribution |
| LP5550C | Outer Diameter 5.5 mm | In distribution |
| LP6535 | Length 35 mm | In distribution |
| LROD70C | Outer Diameter 5.5 mm | In distribution |
| LP7540C | Outer Diameter 7.5 mm | In distribution |
| LP5550 | Length 50 mm | In distribution |
| LP6555 | Outer Diameter 6.5 mm | In distribution |
| LROD40C | Outer Diameter 5.5 mm | In distribution |
| LROD100 | Outer Diameter 5.5 mm | In distribution |
| LP5560 | Length 60 mm | In distribution |
| LP4525 | Outer Diameter 4.5 mm | In distribution |
| LROD70 | Outer Diameter 5.5 mm | In distribution |
| LP6530C | Outer Diameter 6.5 mm | In distribution |
| LP6530 | Length 30 mm | In distribution |
| LP4540 | Outer Diameter 4.5 mm | In distribution |
| LP6550 | Length 50 mm | In distribution |
| LROD80C | Outer Diameter 5.5 mm | In distribution |
| LP5555 | Length 55 mm | In distribution |
| LROD40 | Length 40 mm | In distribution |
| LP4545 | Outer Diameter 4.5 mm | In distribution |
| LROD120 | Outer Diameter 5.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,144 |
| Anax™ 5.5 Spinal System | CG MedTech Co., Ltd. | 2,177 |
| ReLine | Nuvasive, Inc. | 2,010 |
| Creo | Globus Medical, Inc. | 1,619 |
| Perfix™ Spinal System | CG MedTech Co., Ltd. | 1,476 |
| Apex Spine System | Spinecraft LLC | 1,193 |
| Olympic | Astura Medical | 1,173 |
| Arsenal | Alphatec Spine, Inc. | 1,001 |
| Revere | Globus Medical, Inc. | 997 |
| Astra Spine System | Spinecraft LLC | 798 |
| Apex-DL Spine System | Spinecraft LLC | 735 |
| Zenius Spinal System | Medyssey Co., Ltd. | 712 |
Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.