Vertex® Reconstruction System
Connector G7755325 LP OC Screw Connector
13manufacturers in China registered for this device type
69catalogue numbers in this listing
23510(k) clearances naming this product 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, Spinal Pedicle Fixation
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K053483 |
| Record published | 2015-07-27 |
| Record revised | 2019-05-07 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 6 to 300 mm; outer diameter 3.2 to 5 mm; width 20 to 40 mm; circumference 3.5 mm |
| Distribution end date | 2019-05-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6959524 | In distribution | |
| G6959428 | Length 28.0 mm | In distribution |
| G6959430 | Length 30.0 mm | In distribution |
| X0411399 | Outer Diameter 3.5 mm | In distribution |
| X0307411 | Width 36.0 mm | In distribution |
| X0411398 | Outer Diameter 3.5 mm | In distribution |
| 6959448 | In distribution | |
| X0307413 | Width 40.0 mm | In distribution |
| G7750508 | Length 8.0 mm | In distribution |
| X0411395 | Outer Diameter 3.5 mm | In distribution |
| 7750512 | Outer Diameter 4.5 mm | In distribution |
| 6959422 | In distribution | |
| 6959444 | In distribution | |
| 7750516 | Length 16.0 mm | In distribution |
| 6959432 | In distribution | |
| 7750508 | Outer Diameter 4.5 mm | In distribution |
| 7751110 | In distribution | |
| 6959440PT | In distribution | |
| 6959440 | In distribution | |
| 6959426PT | In distribution | |
| 6959436 | In distribution | |
| 6955270 | Outer Diameter 3.2 mm | In distribution |
| X0411393 | Outer Diameter 3.5 mm | In distribution |
| 6959424PT | In distribution | |
| 7750610 | Length 10.0 mm | In distribution |
| X0307412 | Width 38.0 mm | In distribution |
| 6959442 | In distribution | |
| 6959428PT | In distribution | |
| 7750606 | Length 6.0 mm | In distribution |
| G7755325 | SMALL | In distribution |
| 7755271 | Outer Diameter 3.5 mm | In distribution |
| 7750510 | Length 10.0 mm | In distribution |
| 6959530 | In distribution | |
| G6959436 | Outer Diameter 4.0 mm | In distribution |
| 6959528 | In distribution | |
| 7750614 | Outer Diameter 5.0 mm | In distribution |
| X0307409 | Width 32.0 mm | In distribution |
| 6959514 | In distribution | |
| 6959438 | In distribution | |
| G7750614 | Length 14.0 mm | In distribution |
| 6959426 | In distribution | |
| X0307410 | Width 34.0 mm | In distribution |
| G7750512 | Outer Diameter 4.5 mm | In distribution |
| 6955274 | Width 36.0 mm | In distribution |
| 6959512 | In distribution | |
| G6959434 | Length 34.0 mm | In distribution |
| 7750518 | Outer Diameter 4.5 mm | In distribution |
| G7755124 | Length 220.0 mm | In distribution |
| G7750618 | Outer Diameter 5.0 mm | In distribution |
| G7755327 | Large | In distribution |
| 6955273 | Width 24.0 mm | In distribution |
| 6959516 | In distribution | |
| 7750010 | Circumference 3.5 mm | In distribution |
| X0307403 | Width 20.0 mm | In distribution |
| 7750618 | Length 18.0 mm | In distribution |
| 6959450 | In distribution | |
| X0411396 | Outer Diameter 3.5 mm | In distribution |
| 6959430PT | In distribution | |
| X0307407 | Width 28.0 mm | In distribution |
| 6959424 | In distribution | |
| G6959424 | Outer Diameter 4.0 mm | In distribution |
| G7750516 | Length 16.0 mm | In distribution |
| 7750077 | Withdrawn | |
| X1108036 | Withdrawn | |
| 7750092 | Length 300.0 mm | Withdrawn |
| 7750045 | Length 80.0 mm | Withdrawn |
| 7755272 | Outer Diameter 4.0 mm | Withdrawn |
| X1108010 | Withdrawn | |
| 7750080 | Length 80.0 mm | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K062879 | 2006-12-22 |
| K062606 | 2006-09-25 |
| K053483 | 2006-01-05 |
| K042210 | 2004-11-04 |
| K042453 | 2004-10-07 |
| K041777 | 2004-09-03 |
| K041030 | 2004-06-30 |
| K041118 | 2004-05-28 |
| K040583 | 2004-03-31 |
| K033495 | 2003-12-03 |
| K033271 | 2003-11-06 |
| K031967 | 2003-09-17 |
| K032578 | 2003-09-17 |
| K032037 | 2003-09-04 |
| K031833 | 2003-09-03 |
| K031888 | 2003-06-27 |
| K030932 | 2003-05-16 |
| K030840 | 2003-05-15 |
| K022778 | 2002-09-18 |
| K021106 | 2002-05-03 |
| K011029 | 2001-06-05 |
| K011067 | 2001-05-04 |
| K000991 | 2000-04-18 |
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.