Streamline MIS Spinal Fixation System
Ø6.5mm X 100mm DL MIS Pedicle Screw Assy
13manufacturers in China registered for this device type
103catalogue numbers in this listing
4recalls on this code
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 | Xtant Medical Holdings, 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 |
| 510(k) | K192396 |
| Record published | 2026-04-30 |
| Record revised | 2025-04-08 (version 9) |
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 |
| Distribution end date | 2023-10-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04-55-RR-40 | In distribution | |
| 04-55-RR-200 | In distribution | |
| 04-55-PR-65 | In distribution | |
| 51-GW-500-BLUNT-SS | In distribution | |
| 05-PA-85-50 | In distribution | |
| 04-55-PR-160 | In distribution | |
| 05-PA-75-85 | In distribution | |
| 05-PA-75-65 | In distribution | |
| 04-55-PR-110 | In distribution | |
| 05-PA-65-100 | 6.5mm (D) 100mm (L) | In distribution |
| 04-55-RR-65 | In distribution | |
| 05-PA-95-70 | 9.5mm (D) 70mm (L) | In distribution |
| 04-55-RR-130 | In distribution | |
| 05-PA-75-60 | In distribution | |
| 04-55-RR-140 | In distribution | |
| 05-PA-65-30 | In distribution | |
| 51-GW-550-BLUNT | In distribution | |
| 51-GW-500-SHARP-SS | In distribution | |
| 04-55-RR-60 | In distribution | |
| 05-PA-65-75 | 6.5mm (D) 75mm (L) | In distribution |
| 05-PA-65-70 | 6.5mm (D) 70mm (L) | In distribution |
| 05-PA-75-30 | In distribution | |
| 05-PA-95-60 | In distribution | |
| 05-PA-85-70 | In distribution | |
| 04-55-RR-70 | In distribution | |
| 05-PA-75-75 | In distribution | |
| 05-PA-95-80 | 9.5mm (D) 80mm (L) | In distribution |
| 04-55-RR-240 | In distribution | |
| 04-55-RR-210 | In distribution | |
| 05-PA-85-40 | In distribution | |
| 04-55-PR-170 | In distribution | |
| 05-PA-55-40 | In distribution | |
| 05-PA-45-25 | In distribution | |
| 05-PA-75-55 | In distribution | |
| 04-55-PR-55 | In distribution | |
| 04-55-PR-140 | In distribution | |
| 51-GW-500-SHARP | In distribution | |
| 05-PA-75-50 | In distribution | |
| 05-PA-75-95 | In distribution | |
| 04-55-RR-90 | In distribution | |
| 04-55-RR-250 | In distribution | |
| 05-PA-85-65 | In distribution | |
| 04-55-PR-60 | In distribution | |
| 05-PA-95-40 | In distribution | |
| 04-55-RR-45 | In distribution | |
| 05-PA-85-80 | In distribution | |
| 04-55-RR-100 | In distribution | |
| 05-PA-65-65 | 6.5mm (D) 65mm (L) | In distribution |
| 04-PA-85-55 | 8.5mm (D) x 55mm (L) | Withdrawn |
| 04-55-PR-180 | Withdrawn | |
| 04-PA-95-40 | 9.5mm (D) x 40mm (L) | Withdrawn |
| 04-PA-95-100 | 9.5mm (D) x 100mm (L) | Withdrawn |
| 05-PA-95-90 | 9.5mm (D) 90mm (L) | Withdrawn |
| 04-PA-75-45 | 7.5mm (D) x 45mm (L) | Withdrawn |
| 05-PA-95-50 | Withdrawn | |
| 04-PA-55-30 | 5.5mm (D) x 30mm (L) | Withdrawn |
| 04-PA-75-50 | 7.5mm (D) x 50mm (L) | Withdrawn |
| 04-PA-75-40 | 7.5mm (D) x 40mm (L) | Withdrawn |
| 05-PA-65-90 | Withdrawn | |
| 04-PA-45-45 | 4.5mm (D) x 45mm (L) | Withdrawn |
| 05-PA-65-45 | Withdrawn | |
| 04-55-PR-170 | Withdrawn | |
| 05-PA-85-55 | Withdrawn | |
| 04-PA-65-90 | 6.5mm (D) x 90mm (L) | Withdrawn |
| 05-PA-75-100 | Withdrawn | |
| 05-PA-55-40 | Withdrawn | |
| 04-55-RR-50 | Withdrawn | |
| 04-PA-85-85 | 8.5mm (D) x 85mm (L) | Withdrawn |
| 05-PA-65-30 | Withdrawn | |
| 04-PA-45-40 | 4.5mm (D) x 40mm (L) | Withdrawn |
| 04-55-PR-70 | Withdrawn | |
| 04-PA-65-85 | 6.5mm (D) x 85mm (L) | Withdrawn |
| 04-55-PR-55 | Withdrawn | |
| 05-PA-75-95 | Withdrawn | |
| 04-55-RR-220 | Withdrawn | |
| 04-PA-85-70 | 8.5mm (D) x 70mm (L) | Withdrawn |
| 05-PA-65-95 | 6.5mm (D) 95mm (L) | Withdrawn |
| 05-PA-75-75 | Withdrawn | |
| 04-PA-85-80 | 8.5mm (D) x 80mm (L) | Withdrawn |
| 05-PA-85-95 | Withdrawn | |
| 04-55-RR-40 | Withdrawn | |
| 04-PA-85-65 | 8.5mm (D) x 65mm (L) | Withdrawn |
| 05-PA-85-35 | Withdrawn | |
| 04-55-RR-80 | Withdrawn | |
| 05-PA-65-65 | 6.5mm (D) 65mm (L) | Withdrawn |
| 05-PA-85-90 | Withdrawn | |
| 05-PA-65-85 | Withdrawn | |
| 04-55-PR-75 | Withdrawn | |
| 04-55-RR-55 | Withdrawn | |
| 04-55-RR-250 | Withdrawn | |
| 04-PA-65-60 | 6.5mm (D) x 60mm (L) | Withdrawn |
| 05-PA-85-45 | Withdrawn | |
| 04-55-PR-90 | Withdrawn | |
| 04-55-RR-100 | Withdrawn | |
| 04-PA-65-45 | 6.5mm (D) x 45mm (L) | Withdrawn |
| 51-GW-500-SHARP-TH | Withdrawn | |
| 05-PA-85-70 | Withdrawn | |
| 04-55-RR-110 | Withdrawn | |
| 51-GW-500-BLUNT-SS | Withdrawn | |
| 05-PA-95-70 | Withdrawn | |
| 04-PA-65-50 | 6.5mm (D) x 50mm (L) | Withdrawn |
| 04-PA-75-70 | 7.5mm (D) x 70mm (L) | Withdrawn |
| 04-PA-85-40 | 8.5mm (D) x 40mm (L) | 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
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 |
|---|---|---|---|---|---|---|---|
| Pioneer Surgical Technology, Inc. | 510(k) number | 2013-06-14 | Class II | Device Design | The affected fixed rod holders did not allow the instrument to lock down on the spinal rod. | 9 | 2014-09-30 |
Recalls
3 of these are 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 |
|---|---|---|---|---|---|
| 2017-04-12 | Class II | Labeling mix-ups | The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium. | 97 units | 2017-08-16 |
| 2015-04-07 | Class II | Other | The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length. | 75 units | 2015-10-01 |
| 2015-03-11 | Class II | Nonconforming Material/Component | One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label. | 14 units | 2015-10-21 |
| 2009-03-24 | Not classified | Process control | A defect cause was discovered following a customer complaint pertaining to a post operative dissociation of the Capless Li Screw construct. The screw assembly is made up of three parts; a cup which locks onto a 5.5mm rod, a yoke that cradl | 9,613 units | 2012-04-25 |
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.