Infinity™ Occipitocervical Upper Thoracic System
Partial Thread MAS G360PT4020 4.0 X 20MM
11manufacturers in China registered for this device type
208catalogue numbers in this listing
44510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 510(k) | K163375 |
| Record published | 2018-06-10 |
| Record revised | 2023-07-26 (version 9) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 3603542 | 3.5mm x 42mm | In distribution | |
| G3603014 | 3.0mm x 14mm | In distribution | |
| 36537055 | In distribution | ||
| 36537070 | In distribution | ||
| G360PT4020 | 4.0mm x 20mm | In distribution | |
| 3603730 | 3.5mm x 30mm | In distribution | |
| 3607022 | In distribution | ||
| 360PT3536 | 3.5mm x 36mm | In distribution | |
| 3604542 | 4.5mm x 42mm | In distribution | |
| 36537040 | In distribution | ||
| G360PT3526 | 3.5mm x 26mm | In distribution | |
| 36537090 | In distribution | ||
| G3606074L | 6.0mm | In distribution | |
| G3602526 | MEDIUM (30mm-40mm) | In distribution | |
| 3603510 | 3.5mm x 10mm | In distribution | |
| 3603709 | 3.5mm/6.0mm x 420mm | In distribution | |
| G3603526 | 3.5mm x 26mm | In distribution | |
| 3607024 | In distribution | ||
| 3603018 | 3.0mm x 18mm | In distribution | |
| 3605240 | 3.5mm x 240mm | In distribution | |
| 3603528 | 3.5mm x 28mm | In distribution | |
| G3604040 | 4.0mm x 40mm | In distribution | |
| 3603740 | 3.5mm x 40mm | In distribution | |
| G3604526 | 4.5mm x 26mm | In distribution | |
| 3600315 | M6 | In distribution | |
| 360PT4020 | 4.0mm x 20mm | In distribution | |
| 3604530 | 4.5mm x 30mm | In distribution | |
| 3603635 | 3.2/3.5mm to 5.5/6.0/6.35mm | In distribution | |
| 3604030 | 4.0mm x 30mm | In distribution | |
| G36537100 | In distribution | ||
| 3602519A | 19mm | In distribution | |
| 3601350 | 3.2/3.5mm to 3.2/3.5mm | In distribution | |
| G3605530 | 5.5mm X 30mm | In distribution | |
| 360PT4038 | 4.0mm x 38mm | In distribution | |
| 360PT4036 | 4.0mm x 36mm | In distribution | |
| G36537090 | In distribution | ||
| G3600514 | 5.0mm x 14mm | In distribution | |
| 36535100 | In distribution | ||
| G3600315 | M6 | In distribution | |
| 36535120 | In distribution | ||
| G3606069 | 3.2/3.5mm | In distribution | |
| 3602510 | 10mm | In distribution | |
| G36537105 | In distribution | ||
| 3603707 | 3.5mm/5.5mm x 420mm | In distribution | |
| G3603518 | 3.5mm x 18mm | In distribution | |
| G360PT3534 | 3.5mm x 34mm | In distribution | |
| G3604518 | 4.5mm x 18mm | In distribution | |
| 3604036 | 4.0mm x 36mm | In distribution | |
| 3600512 | 5.0mm x 12mm | In distribution | |
| 3600200 | 3.5mm x 200mm | In distribution | |
| G3603032 | 3.0mm x 32mm | In distribution | |
| 3604534 | 4.5mm x 34mm | In distribution | |
| 3602536 | MEDIUM (30mm-40mm) | In distribution | |
| 3603028 | 3.0mm x 28mm | In distribution | |
| G36537130 | In distribution | ||
| G3605540 | 5.5mm X 40mm | In distribution | |
| 3603750 | 3.5mm x 50mm | In distribution | |
| G36535100 | In distribution | ||
| G3603508 | 3.5mm x 8mm | In distribution | |
| G3602519A | 19mm | In distribution | |
| 3603508 | 3.5mm x 8mm | In distribution | |
| G360PT4036 | 4.0mm x 36mm | In distribution | |
| G3604016 | 4.0mm x 16mm | In distribution | |
| 3603807 | 3.5mm/5.5mm x 420mm | In distribution | |
| G36537025 | In distribution | ||
| G36537080 | In distribution | ||
| 3604018 | 4.0mm x 18mm | In distribution | |
| 3604508 | 4.5mm x 8mm | In distribution | |
| 3604522 | 4.5mm x 22mm | In distribution | |
| G3603024 | 3.0mm x 24mm | In distribution | |
| 3604526 | 4.5mm x 26mm | In distribution | |
| 3607011 | In distribution | ||
| G360T0514 | 5.0mm x 14mm | In distribution | |
| G3600301 | OFFSET | In distribution | |
| 3607016 | In distribution | ||
| 3603536 | 3.5mm x 36mm | In distribution | |
| G3603030 | 3.0mm x 30mm | In distribution | |
| G3600215 | In distribution | ||
| 3607021 | In distribution | ||
| 3603540 | 3.5mm x 40mm | In distribution | |
| 3603350 | 3.2/3.5mm to 3.2/3.5mm | In distribution | |
| G360PT3530 | 3.5mm x 30mm | In distribution | |
| 3603808 | 3.5mm/6.0mm x 600mm | In distribution | |
| 3607017 | In distribution | ||
| G360PT4028 | 4.0mm x 28mm | In distribution | |
| 360PT3522 | 3.5mm x 22mm | In distribution | |
| 3602513 | 13mm | In distribution | |
| G3606074 | 6.0mm | In distribution | |
| 3600215 | In distribution | ||
| G3603540 | 3.5mm x 40mm | In distribution | |
| 3600506 | 5.0mm x 6mm | In distribution | |
| G3603538 | 3.5mm x 38mm | In distribution | |
| G3600210 | 3.5mm x 200mm | In distribution | |
| G360T0408 | 4.5mm x 8mm | In distribution | |
| 3603725 | 3.5mm x 25mm | In distribution | |
| 3601475 | 3.2/3.5mm to 4.5/4.75mm | In distribution | |
| 3604032 | 4.0mm x 32mm | In distribution | |
| 3604020 | 4.0mm x 20mm | In distribution | |
| G360PT3520 | 3.5mm x 20mm | In distribution | |
| G3600510 | 5.0mm x 10mm | In distribution | |
| 3603020 | 3.0mm x 20mm | In distribution | |
| 360PT4028 | 4.0mm x 28mm | In distribution | |
| 36537025 | In distribution | ||
| G36537085 | In distribution | ||
| G3603016 | 3.0mm x 16mm | In distribution | |
| 3604038 | 4.0mm x 38mm | In distribution | |
| 360T0508 | 5.0mm x 8mm | In distribution | |
| G3603516 | 3.5mm x 16mm | In distribution | |
| 36535130 | In distribution | ||
| G3600100 | 3.5mm x 100mm | In distribution | |
| G360PT4024 | 4.0mm x 24mm | In distribution | |
| G3603514 | 3.5mm x 14mm | In distribution | |
| G3604014 | 4.0mm x 14mm | In distribution | |
| G3604030 | 4.0mm x 30mm | In distribution | |
| 3601513 | 13mm | In distribution | |
| G36537120 | In distribution | ||
| G3603809 | 3.5mm/6.0mm x 420mm | In distribution | |
| 36537080 | In distribution | ||
| 3603706 | 3.5mm/4.75mm x 420mm | In distribution | |
| G3601516 | 16mm | In distribution | |
| 360PT4030 | 4.0mm x 30mm | In distribution | |
| 3603034 | 3.0mm x 34mm | In distribution | |
| 36537050 | In distribution | ||
| G36537070 | In distribution | ||
| G36535120 | In distribution | ||
| 3603514 | 3.5mm x 14mm | In distribution | |
| 3603008 | 3.0mm x 8mm | In distribution | |
| 3604008 | 4.0mm x 8mm | In distribution | |
| 3607034 | In distribution | ||
| G3603528 | 3.5mm x 28mm | In distribution | |
| G3603350 | 3.2/3.5mm to 3.2/3.5mm | In distribution | |
| 3604014 | 4.0mm x 14mm | In distribution | |
| 3607008 | In distribution | ||
| 360PT4040 | 4.0mm x 40mm | In distribution | |
| 3607033 | In distribution | ||
| 36537030 | In distribution | ||
| 360PT4024 | 4.0mm x 24mm | In distribution | |
| 3600410 | 4.5mm x 10mm | In distribution | |
| G360PT4032 | 4.0mm x 32mm | In distribution | |
| 3602615 | In distribution | ||
| 360PT3526 | 3.5mm x 26mm | In distribution | |
| 360PT3524 | 3.5mm x 24mm | In distribution | |
| G3604038 | 4.0mm x 38mm | In distribution | |
| G3603709 | 3.5mm/6.0mm x 420mm | In distribution | |
| 3603809 | 3.5mm/6.0mm x 420mm | In distribution | |
| 3601510 | 10mm | In distribution | |
| G3600216 | 4 | In distribution | |
| 3603520 | 3.5mm x 20mm | In distribution | |
| G3600412 | 4.5mm x 12mm | In distribution | |
| G3604536 | 4.5mm x 36mm | In distribution | |
| G3603808 | 3.5mm/6.0mm x 600mm | In distribution | |
| G36537065 | In distribution | ||
| G3603020 | 3.0mm x 20mm | In distribution | |
| G3604508 | 4.5mm x 8mm | In distribution | |
| G360T0414 | 4.5mm x 14mm | In distribution | |
| 3607004 | In distribution | ||
| G3602516A | 16mm | In distribution | |
| 3607087 | In distribution | ||
| G360T0406 | 4.5mm x 6mm | In distribution | |
| G3603536 | 3.5mm x 36mm | In distribution | |
| 3607026 | In distribution | ||
| 360PT4032 | 4.0mm x 32mm | In distribution | |
| G3604520 | 4.5mm x 20mm | In distribution | |
| G3605535 | 5.5mm X 35mm | In distribution | |
| 3600600 | SMALL | In distribution | |
| G3603532 | 3.5mm x 32mm | In distribution | |
| 3602516 | 16mm | In distribution | |
| 3603032 | 3.0mm x 32mm | In distribution | |
| G36537075 | In distribution | ||
| 3602526 | MEDIUM (30mm-40mm) | In distribution | |
| 3603532 | 3.5mm x 32mm | In distribution | |
| G36535090 | In distribution | ||
| G3603524 | 3.5mm x 24mm | In distribution | |
| G3600410 | 4.5mm x 10mm | In distribution | |
| 3603780 | 3.5mm x 80mm | In distribution | |
| 360PT4018 | 4.0mm x 18mm | In distribution | |
| G3604032 | 4.0mm x 32mm | In distribution | |
| G3604522 | 4.5mm x 22mm | In distribution | |
| G3602516 | 16mm | In distribution | |
| 3607019 | In distribution | ||
| G3600601 | REGULAR | In distribution | |
| G3603542 | 3.5mm x 42mm | In distribution | |
| G360PT4034 | 4.0mm x 34mm | In distribution | |
| 360PT3532 | 3.5mm x 32mm | In distribution | |
| 3607015 | In distribution | ||
| G36537050 | In distribution | ||
| 3600210 | 3.5mm x 200mm | In distribution | |
| 3603770 | 3.5mm x 70mm | In distribution | |
| 3604520 | 4.5mm x 20mm | In distribution | |
| G3604524 | 4.5mm x 24mm | In distribution | |
| 3604042 | 4.0mm x 42mm | In distribution | |
| G3605520 | 5.5mm X 20mm | In distribution | |
| G360PT3540 | 3.5mm x 40mm | In distribution | |
| 3600100 | 3.5mm x 100mm | In distribution | |
| 3604536 | 4.5mm x 36mm | In distribution | |
| G3600414 | 4.5mm x 14mm | In distribution | |
| 3603516 | 3.5mm x 16mm | In distribution | |
| 36535080 | In distribution | ||
| G3603510 | 3.5mm x 10mm | In distribution | |
| G3604516 | 4.5mm x 16mm | In distribution | |
| G3602615 | In distribution | ||
| G3604514 | 4.5mm x 14mm | In distribution | |
| 3604512 | 4.5mm x 12mm | In distribution | |
| G360PT4018 | 4.0mm x 18mm | In distribution | |
| 3602535 | SMALL (24mm-30mm) | In distribution | |
| 3603030 | 3.0mm x 30mm | In distribution | |
| 3603010 | 3.0mm x 10mm | In distribution | |
| 3602527 | LARGE (40mm-56mm) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Invictus | Alphatec Spine, Inc. | 5,422 |
| ReLine | Nuvasive, Inc. | 4,439 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 3,188 |
| Creo | Globus Medical, Inc. | 1,992 |
| Apex Spine System | Spinecraft LLC | 1,319 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 1,271 |
| Perla ® TL | Spineart SA | 1,035 |
| Astra Spine System | Spinecraft LLC | 1,003 |
| LineSider | Highridge Medical, LLC | 948 |
| Apex-DL Spine System | Spinecraft LLC | 909 |
| Revere | Globus Medical, Inc. | 875 |
| AccelFix Spinal Fixation System | L&K Biomed Co., Ltd. | 841 |
Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121191 | 2012-06-29 |
| K102886 | 2011-01-26 |
| K090714 | 2009-04-17 |
| K083071 | 2008-11-14 |
| K081297 | 2008-06-11 |
| K080805 | 2008-04-18 |
| K071942 | 2007-12-11 |
| K062447 | 2007-10-15 |
| K070742 | 2007-09-14 |
| K061591 | 2006-09-08 |
| K061579 | 2006-08-11 |
| K060081 | 2006-02-13 |
| K052734 | 2005-10-21 |
| K052376 | 2005-09-23 |
| K052402 | 2005-09-23 |
| K052180 | 2005-08-23 |
| K050484 | 2005-05-04 |
| K043053 | 2005-04-11 |
| K043020 | 2005-01-07 |
| K042789 | 2004-12-21 |
| K042524 | 2004-10-08 |
| K042498 | 2004-10-07 |
| K042402 | 2004-10-01 |
| K041862 | 2004-09-15 |
| K041282 | 2004-06-10 |
| K030875 | 2003-06-24 |
| K031533 | 2003-06-13 |
| K030816 | 2003-06-06 |
| K023415 | 2002-12-13 |
| K023797 | 2002-12-13 |
| K014296 | 2002-12-10 |
| K023555 | 2002-11-22 |
| K022191 | 2002-08-28 |
| K021061 | 2002-07-25 |
| K022070 | 2002-07-22 |
| K022015 | 2002-07-18 |
| K020709 | 2002-05-09 |
| K020426 | 2002-02-26 |
| K020155 | 2002-02-05 |
| K014267 | 2002-01-25 |
| K003780 | 2001-09-28 |
| K011508 | 2001-06-12 |
| K010181 | 2001-06-12 |
| K001532 | 2000-06-16 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2023-02-16 | Class II | Under Investigation by firm | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws | 45 units |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2023-02-16 | Class II | Under Investigation by firm | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws | 10 units |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2023-02-16 | Class II | Under Investigation by firm | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws | 2 units |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2023-02-16 | Class II | Under Investigation by firm | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws | 90 units |
| Medtronic Sofamor Danek USA, Inc. | 510(k) number | 2023-02-16 | Class II | Under Investigation by firm | Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws | 13 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.