Leucadia Pedicle Screw System
Locking NUT, Final Assembly, Hexalobe
13manufacturers in China registered for this device type
33catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
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 | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | MNH |
| Device type | Orthosis, Spondylolisthesis Spinal Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K110588 |
| Record published | 2014-09-24 |
| Record revised | 2025-07-14 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 4.5 to 8 mm; length 30 to 105 mm; width 50 mm |
| Distribution end date | 2017-11-10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LC-CR5570 | Outer Diameter 5.5 mm | Withdrawn |
| LC-PR0845 | Length 45 mm | Withdrawn |
| LC-CR5565 | Length 65 mm | Withdrawn |
| LC-PS0760 | Length 60 mm | Withdrawn |
| LC-CR5595 | Outer Diameter 5.5 mm | Withdrawn |
| LC-CR55105 | Length 105 mm | Withdrawn |
| LG-LN1004 | Withdrawn | |
| LC-PS0870 | Outer Diameter 8 mm | Withdrawn |
| LC-PS0730 | Length 30 mm | Withdrawn |
| LC-PR0760 | Length 60 mm | Withdrawn |
| LC-PS0560 | Length 60 mm | Withdrawn |
| LC-PR0750 | Outer Diameter 7 mm | Withdrawn |
| LC-PS0865 | Length 65 mm | Withdrawn |
| LC-PS0840 | Length 40 mm | Withdrawn |
| LC-PS0630 | Outer Diameter 6 mm | Withdrawn |
| LC-PS07100 | Length 100 mm | Withdrawn |
| LC-PS0665 | Length 65 mm | Withdrawn |
| LC-PR0755 | Length 55 mm | Withdrawn |
| LC-PS4545 | Outer Diameter 4.5 mm | Withdrawn |
| LG-CC1002 | Width 50 mm | Withdrawn |
| LC-PR07100 | Outer Diameter 7 mm | Withdrawn |
| LC-PS0830 | Outer Diameter 8 mm | Withdrawn |
| LC-PS08100 | Length 100 mm | Withdrawn |
| LC-PS4540 | Outer Diameter 4.5 mm | Withdrawn |
| LC-PS4535 | Length 35 mm | Withdrawn |
| LC-PR08100 | Outer Diameter 8 mm | Withdrawn |
| RD-PB5509 | Length 90 mm | Withdrawn |
| LC-PR0890 | Length 90 mm | Withdrawn |
| LC-PS0650 | Length 50 mm | Withdrawn |
| LC-PR0535 | Outer Diameter 5 mm | Withdrawn |
| LC-PR0555 | Length 55 mm | Withdrawn |
| LC-PS0755 | Outer Diameter 7 mm | Withdrawn |
| LC-PS0540 | Outer Diameter 5 mm | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K090228 | 2009-04-29 |
| K071890 | 2007-11-09 |
| K061321 | 2006-07-07 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Allez Spine, LLC | 510(k) number | 2008-08-21 | Not classified | Pending | This action is being taken voluntarily as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The Company decided it could better address the FDA’s concerns regarding Current Good Manufacturing Practice | 6472 units for all systems | 2010-01-19 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-09-25 | Class II | Nonconforming Material/Component | The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti Cannulated Polyaxial Screws, therefore rendering such screws nonfunction | 209 screws | 2013-03-29 |
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.