Sniper® Spine System
Sniper is a posterior screw-and-rod system that forms a rigid construct to stabilize the non-cervical spine during vertebral fusion. Its titanium-alloy implants are supplied nonsterile for…
Sniper is a posterior screw-and-rod system that forms a rigid construct to stabilize the non-cervical spine during vertebral fusion. Its titanium-alloy implants are supplied nonsterile for single use and are intended to be removed after fusion is achieved.
The family includes percutaneous cannulated screws and rods, used with dedicated percutaneous instruments for a posterior approach. The filed cannulated extended-tab pedicle screw is one component of this broader fixation system.
Listed Item
Cannulated Extended Tab Pedicle Screw 5.5mm x 50mm
Fixation Scope
The system is intended for skeletally mature patients. One specified configuration addresses severe Grade 3 or 4 spondylolisthesis at L5-S1, with fixation from L3 to S1 and autogenous bone graft. The levels and configuration depend on the indication.
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, Spinal Pedicle Fixation
Record
| Listed by | Spine Wave, Inc., United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K152174 |
| Record published | 2015-10-24 |
| 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 | Length 30 to 500 mm; outer diameter 5.5 to 7.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11-4551 | Length 50 mm | In distribution |
| 11-4500 | Outer Diameter 5.5 mm | In distribution |
| 11-4002 | In distribution | |
| 11-4541 | Length 40 mm | In distribution |
| 11-4641 | Length 40 mm | In distribution |
| 11-4651 | Length 50 mm | In distribution |
| 11-4751 | Length 50 mm | In distribution |
| 11-4531 | Length 30 mm | In distribution |
| 11-4731 | Length 30 mm | In distribution |
| 11-4631 | Length 30 mm | In distribution |
| 11-4741 | Length 40 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160003 | 2016-02-26 |
| K152174 | 2015-08-31 |
| K151813 | 2015-07-31 |
| K132154 | 2013-08-09 |
| K122233 | 2012-10-11 |
| K120646 | 2012-06-07 |
| K111913 | 2011-08-31 |
| K083743 | 2009-01-13 |
| K083353 | 2008-12-11 |
| K081228 | 2008-05-12 |
| K070245 | 2007-04-05 |
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.