Streamline MIS Spinal Fixation System
Guidewire 1.5mm X 500mm, Blunt Tip - NIT
13manufacturers in China registered for this device type
121catalogue numbers in this listing
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, Spinal Pedicle Fixation
Record
| Listed by | Xtant Medical Holdings, 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, Complaint-file establishment, Manufacturer |
| 510(k) | K192396 |
| Record published | 2021-08-20 |
| Record revised | 2025-04-08 (version 9) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| 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 |
|---|---|---|
| 05-PA-45-45 | In distribution | |
| 04-55-RR-35 | In distribution | |
| 51-GW-500-BLUNT | In distribution | |
| 04-55-RR-220 | In distribution | |
| 05-PA-85-85 | In distribution | |
| 04-55-RR-110 | In distribution | |
| 05-PA-95-100 | 9.5mm (D) 100mm (L) | In distribution |
| 05-PA-55-45 | In distribution | |
| 05-PA-65-55 | In distribution | |
| 04-55-PR-200 | In distribution | |
| 05-PA-75-40 | In distribution | |
| 51-GW-500-BLUNT-TH | In distribution | |
| 04-55-PR-90 | In distribution | |
| 04-55-RR-350 | In distribution | |
| 05-PA-45-40 | In distribution | |
| 04-55-PR-50 | In distribution | |
| 05-PA-85-100 | In distribution | |
| 05-PA-85-75 | In distribution | |
| 04-55-PR-130 | In distribution | |
| 05-PA-65-45 | In distribution | |
| 04-55-RR-180 | In distribution | |
| 04-55-PR-120 | In distribution | |
| 05-PA-85-95 | In distribution | |
| 51-GW-500-SHARP-TH | In distribution | |
| 04-55-RR-150 | In distribution | |
| 05-PA-55-50 | In distribution | |
| 05-PA-95-90 | 9.5mm (D) 90mm (L) | In distribution |
| 05-PA-75-45 | In distribution | |
| 05-PA-55-60 | 5.5mm (D) 60mm (L) | In distribution |
| 05-PA-65-85 | 6.5mm (D) 85mm (L) | In distribution |
| 04-55-RR-160 | In distribution | |
| 05-PA-95-50 | In distribution | |
| 04-55-PR-35 | In distribution | |
| 05-PA-85-45 | In distribution | |
| 04-55-RR-50 | In distribution | |
| 04-55-RR-300 | In distribution | |
| 04-55-RR-230 | In distribution | |
| 04-55-PR-150 | In distribution | |
| 04-55-RR-75 | In distribution | |
| 05-PA-85-30 | In distribution | |
| 04-55-PR-70 | In distribution | |
| 05-PA-55-35 | In distribution | |
| 05-PA-65-90 | 6.5mm (D) 90mm (L) | In distribution |
| 05-PA-55-55 | In distribution | |
| 05-PA-95-55 | In distribution | |
| 05-PA-65-35 | In distribution | |
| 04-55-RR-180 | Withdrawn | |
| 05-PA-65-80 | 6.5mm (D) 80mm (L) | Withdrawn |
| 04-PA-95-90 | 9.5mm (D) x 90mm (L) | Withdrawn |
| 04-PA-75-95 | 7.5mm (D) x 95mm (L) | Withdrawn |
| 05-PA-85-85 | Withdrawn | |
| 04-PA-55-55 | 5.5mm (D) x 55mm (L) | Withdrawn |
| 04-55-PR-45 | Withdrawn | |
| 51-GW-500-BLUNT-TH | Withdrawn | |
| 04-PA-85-35 | 8.5mm (D) x 35mm (L) | Withdrawn |
| 04-55-RR-130 | Withdrawn | |
| 05-PA-45-30 | Withdrawn | |
| 51-GW-550-BLUNT | Withdrawn | |
| 04-PA-65-40 | 6.5mm (D) x 40mm (L) | Withdrawn |
| 05-PA-85-40 | Withdrawn | |
| 05-PA-95-100 | 9.5mm (D) 100mm (L) | Withdrawn |
| 51-GW-500-SHARP | Withdrawn | |
| 04-PA-75-55 | 7.5mm (D) x 55mm (L) | Withdrawn |
| 04-55-PR-40 | Withdrawn | |
| 04-PA-85-95 | 8.5mm (D) x 95mm (L) | Withdrawn |
| 04-55-RR-65 | Withdrawn | |
| 05-PA-85-75 | Withdrawn | |
| 04-PA-95-60 | 9.5mm (D) x 60mm (L) | Withdrawn |
| 05-PA-65-65 | Withdrawn | |
| 04-PA-75-85 | 7.5mm (D) x 85mm (L) | Withdrawn |
| 51-GW-500-SHARP-SS | Withdrawn | |
| 04-55-RR-200 | Withdrawn | |
| 04-55-RR-230 | Withdrawn | |
| 04-55-PR-200 | 5.5mm (D) X 200mm (L) | Withdrawn |
| 05-PA-55-60 | Withdrawn | |
| 05-PA-45-35 | Withdrawn | |
| 05-PA-75-65 | Withdrawn | |
| 05-PA-55-50 | Withdrawn | |
| 04-PA-75-90 | 7.5mm (D) x 90mm (L) | Withdrawn |
| 05-PA-85-65 | Withdrawn | |
| 04-55-RR-210 | Withdrawn | |
| 04-55-PR-150 | Withdrawn | |
| 05-PA-65-90 | 6.5mm (D) 90mm (L) | Withdrawn |
| 04-PA-55-45 | 5.5mm (D) x 45mm (L) | Withdrawn |
| 05-PA-95-40 | Withdrawn | |
| 05-PA-65-75 | Withdrawn | |
| 04-55-RR-150 | Withdrawn | |
| 05-PA-65-55 | Withdrawn | |
| 05-PA-85-30 | Withdrawn | |
| 51-GW-500-BLUNT | Withdrawn | |
| 05-PA-65-100 | Withdrawn | |
| 05-PA-65-35 | Withdrawn | |
| 04-PA-45-20 | 4.5mm (D) x 20mm (L) | Withdrawn |
| 05-PA-55-60 | 5.5mm (D) 60mm (L) | Withdrawn |
| 05-PA-75-70 | Withdrawn | |
| 04-55-PR-130 | Withdrawn | |
| 04-PA-85-75 | 8.5mm (D) x 75mm (L) | Withdrawn |
| 05-PA-45-40 | Withdrawn | |
| 05-PA-65-80 | Withdrawn | |
| 05-PA-75-55 | Withdrawn | |
| 04-55-PR-160 | Withdrawn | |
| 04-55-PR-100 | Withdrawn | |
| 04-55-RR-140 | Withdrawn | |
| 04-55-PR-110 | Withdrawn | |
| 05-PA-45-45 | Withdrawn | |
| 05-PA-85-50 | Withdrawn | |
| 04-PA-95-55 | 9.5mm (D) x 55mm (L) | Withdrawn |
| 05-PA-95-90 | Withdrawn | |
| 05-PA-45-25 | Withdrawn | |
| 05-PA-95-80 | 9.5mm (D) 80mm (L) | Withdrawn |
| 05-PA-95-70 | 9.5mm (D) 70mm (L) | Withdrawn |
| 05-PA-65-40 | Withdrawn | |
| 04-PA-85-45 | 8.5mm (D) x 45mm (L) | Withdrawn |
| 04-PA-85-90 | 8.5mm (D) x 90mm (L) | Withdrawn |
| 05-PA-65-50 | Withdrawn | |
| 04-55-RR-45 | Withdrawn | |
| 05-PA-75-40 | Withdrawn | |
| 05-PA-85-100 | Withdrawn | |
| 04-55-RR-160 | Withdrawn | |
| 05-PA-55-35 | Withdrawn | |
| 04-PA-75-60 | 7.5mm (D) x 60mm (L) | Withdrawn |
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
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
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 |
|---|---|---|---|---|
| 2026-02-18 | Class II | Under Investigation by firm | Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is. | 2 units |
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.