Pillar TL
Pillar TL Peek Partial VBR System, Implant/Instrument Case (45-0051)
3manufacturers in China registered for this device type
35catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Orthofix US LLC, United States |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K060350 |
| Record published | 2019-03-19 |
| Record revised | 2026-02-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 45-7415 | In distribution | |
| 45-7208 | In distribution | |
| 45-7413 | In distribution | |
| 45-7408 | In distribution | |
| 45-7306 | In distribution | |
| 45-7215 | In distribution | |
| 45-7414 | In distribution | |
| 45-7313 | In distribution | |
| 45-7309 | In distribution | |
| 45-7308 | In distribution | |
| 45-7310 | In distribution | |
| 45-7209 | In distribution | |
| 45-7211 | In distribution | |
| 45-7411 | In distribution | |
| 45-7316 | In distribution | |
| 45-7315 | In distribution | |
| 45-7307 | In distribution | |
| 45-7312 | In distribution | |
| 450211-0001 | In distribution | |
| 45-7213 | In distribution | |
| 45-7314 | In distribution | |
| 45-7410 | In distribution | |
| 45-7412 | In distribution | |
| 45-7210 | In distribution | |
| 450209-0001 | In distribution | |
| 45-7406 | In distribution | |
| 45-7409 | In distribution | |
| 45-7216 | In distribution | |
| 45-7416 | In distribution | |
| 450207-0001 | In distribution | |
| 45-7214 | In distribution | |
| 45-7407 | In distribution | |
| 45-7207 | In distribution | |
| 45-7206 | In distribution | |
| 45-7311 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 1,514 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 1,509 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,189 |
| Fortify | Globus Medical, Inc. | 866 |
| Matrixx System | Nexxt Spine LLC | 748 |
| Ascend | Alphatec Spine, Inc. | 555 |
| Zavation VBR Trial | Zavation | 548 |
| Verte-Stack® Spinal System | Medtronic Sofamor Danek, Inc. | 484 |
| Timberline® Lateral Interbody Fusion System | Biomet Spine | 470 |
| Timberline Lateral Fusion System | Biomet Spine | 459 |
| Novel | Alphatec Spine, Inc. | 447 |
| Hawkeye™ Vertebral Body Replacement (VBR) | Choice Spine, LP | 368 |
Showing 12 of 683. All products under Spinal Vertebral Body Replacement Device
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-11-19 | Not classified | Nonconforming Material/Component | The Pillar SA Implant Insertion Instrument 49-1100 may experience resistance in turning the activation knob while releasing an implant after intra-operative positioning. | 29 instruments | 2010-02-02 |
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.