Infinity™ Occipitocervical Upper Thoracic System
Rmas PT G365PT4022 3.5MM Screw 4.0X22 ST
4manufacturers in China registered for this device type
375catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shandong (1), Fujian (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| 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 | NKG |
| Device type | Posterior Cervical Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3075 |
| 510(k) | K253129 |
| Record published | 2026-03-22 |
| Record revised | 2022-09-16 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 365PT4028 | In distribution | ||
| G365PT4022 | In distribution | ||
| G3653538 | In distribution | ||
| 3653534 | In distribution | ||
| G365PT4040 | In distribution | ||
| G3602537 | LARGE (40mm-56mm) | In distribution | |
| G36537060 | In distribution | ||
| 365PT4024 | In distribution | ||
| 3655540 | In distribution | ||
| 360PT3520 | 3.5mm x 20mm | In distribution | |
| 3654510 | In distribution | ||
| 3600301 | OFFSET | In distribution | |
| 3604510 | 4.5mm x 10mm | In distribution | |
| 36537075 | In distribution | ||
| 36537060 | In distribution | ||
| G3601513 | 13mm | In distribution | |
| G365PT4030 | In distribution | ||
| 3653520 | In distribution | ||
| 3604034 | 4.0mm x 34mm | In distribution | |
| 365PT4020 | In distribution | ||
| G360T0506 | 5.0mm x 6mm | In distribution | |
| 3604010 | 4.0mm x 10mm | In distribution | |
| 360T0506 | 5.0mm x 6mm | In distribution | |
| 3603806 | 3.5mm/4.75mm x 420mm | In distribution | |
| 3603022 | 3.0mm x 22mm | In distribution | |
| G3603010 | 3.0mm x 10mm | In distribution | |
| G360PT4040 | 4.0mm x 40mm | In distribution | |
| G3606073 | 4.5mm | In distribution | |
| 3653542 | In distribution | ||
| G36535130 | In distribution | ||
| 3655525 | In distribution | ||
| 3604024 | 4.0mm x 24mm | In distribution | |
| G3654040 | In distribution | ||
| 3654030 | In distribution | ||
| G3603022 | 3.0mm x 22mm | In distribution | |
| G360PT3532 | 3.5mm x 32mm | In distribution | |
| 3600412 | 4.5mm x 12mm | In distribution | |
| G3600120 | In distribution | ||
| G3655530 | In distribution | ||
| G3604008 | 4.0mm x 8mm | In distribution | |
| G3654512 | In distribution | ||
| 3603475 | 3.2/3.5mm to 4.5/4.75mm | In distribution | |
| G3600406 | 4.5mm x 6mm | In distribution | |
| G3603522 | 3.5mm x 22mm | In distribution | |
| 3600408 | 4.5mm x 8mm | In distribution | |
| 365PT3532 | In distribution | ||
| G36537045 | In distribution | ||
| G3654030 | In distribution | ||
| G360PT4026 | 4.0mm x 26mm | In distribution | |
| G365PT4038 | In distribution | ||
| G3606073L | 4.5mm | In distribution | |
| G3603012 | 3.0mm x 12mm | In distribution | |
| G3654520 | In distribution | ||
| 3607001 | In distribution | ||
| G3653508 | In distribution | ||
| G3603008 | 3.0mm x 8mm | In distribution | |
| 3603524 | 3.5mm x 24mm | In distribution | |
| 360PT3534 | 3.5mm x 34mm | In distribution | |
| 3654014 | In distribution | ||
| G36537040 | In distribution | ||
| G360PT3518 | 3.5mm x 18mm | In distribution | |
| G3654514 | In distribution | ||
| G3603034 | 3.0mm x 34mm | In distribution | |
| 365PT3520 | In distribution | ||
| 3654534 | In distribution | ||
| 3653536 | In distribution | ||
| G3653524 | In distribution | ||
| 3607007 | In distribution | ||
| G360PT3528 | 3.5mm x 28mm | In distribution | |
| 3654018 | In distribution | ||
| 3653532 | In distribution | ||
| 3604538 | 4.5mm x 38mm | In distribution | |
| 3654530 | In distribution | ||
| G360T0412 | 4.5mm x 12mm | In distribution | |
| G365PT3536 | In distribution | ||
| G365PT3524 | In distribution | ||
| G36537035 | In distribution | ||
| 3603512 | 3.5mm x 12mm | In distribution | |
| G3654522 | In distribution | ||
| G365PT3518 | In distribution | ||
| 3607013 | In distribution | ||
| G3602525 | SMALL (24mm-30mm) | In distribution | |
| 3653518 | In distribution | ||
| 360T0510 | 5.0mm x 10mm | In distribution | |
| G3603530 | 3.5mm x 30mm | In distribution | |
| G3604542 | 4.5mm x 42mm | In distribution | |
| 36537045 | In distribution | ||
| 365PT3534 | In distribution | ||
| 3603016 | 3.0mm x 16mm | In distribution | |
| 36535060 | In distribution | ||
| 3603026 | 3.0mm x 26mm | In distribution | |
| 360T0412 | 4.5mm x 12mm | In distribution | |
| G36535060 | In distribution | ||
| G3603512 | 3.5mm x 12mm | In distribution | |
| G3604510 | 4.5mm x 10mm | In distribution | |
| 3600601 | REGULAR | In distribution | |
| 3654516 | In distribution | ||
| 3607028 | In distribution | ||
| 3600211 | 3.5mm x 200mm | In distribution | |
| 3600120 | In distribution | ||
| 3654532 | In distribution | ||
| G3655520 | In distribution | ||
| 365PT3530 | In distribution | ||
| G3600300 | REGULAR | In distribution | |
| G3604532 | 4.5mm x 32mm | In distribution | |
| 365PT4022 | In distribution | ||
| G3654518 | In distribution | ||
| G3604534 | 4.5mm x 34mm | In distribution | |
| G365PT3534 | In distribution | ||
| 365PT3522 | In distribution | ||
| G3600408 | 4.5mm x 8mm | In distribution | |
| 3604016 | 4.0mm x 16mm | In distribution | |
| 3607010 | In distribution | ||
| G3602616 | In distribution | ||
| G360PT4030 | 4.0mm x 30mm | In distribution | |
| 3604028 | 4.0mm x 28mm | In distribution | |
| 3654520 | In distribution | ||
| G365PT4024 | In distribution | ||
| 3654526 | In distribution | ||
| G3602535 | SMALL (24mm-30mm) | In distribution | |
| 3653512 | In distribution | ||
| 3653538 | In distribution | ||
| G360PT3524 | 3.5mm x 24mm | In distribution | |
| G3602527 | LARGE (40mm-56mm) | In distribution | |
| G3600110 | 3.5mm x 100mm | In distribution | |
| 365PT3524 | In distribution | ||
| 360PT3540 | 3.5mm x 40mm | In distribution | |
| 3605120 | 3.5mm x 120mm | In distribution | |
| G3601510 | 10mm | In distribution | |
| G360T0410 | 4.5mm x 10mm | In distribution | |
| G3653536 | In distribution | ||
| G36537055 | In distribution | ||
| 3603534 | 3.5mm x 34mm | In distribution | |
| G3602519 | 19mm | In distribution | |
| 3653510 | In distribution | ||
| G3604026 | 4.0mm x 26mm | In distribution | |
| 3607020 | In distribution | ||
| G3604020 | 4.0mm x 20mm | In distribution | |
| G3654530 | In distribution | ||
| 360PT4026 | 4.0mm x 26mm | In distribution | |
| G3605515 | 5.5mm X 15mm | In distribution | |
| 3654028 | In distribution | ||
| 3603708 | 3.5mm/6.0mm x 600mm | In distribution | |
| 3600201 | 3.5mm x 200mm | In distribution | |
| 3604524 | 4.5mm x 24mm | In distribution | |
| G3654524 | In distribution | ||
| G3653526 | In distribution | ||
| G3654526 | In distribution | ||
| 360PT3538 | 3.5mm x 38mm | In distribution | |
| G3654012 | In distribution | ||
| G3654028 | In distribution | ||
| 3654514 | In distribution | ||
| 360T0408 | 4.5mm x 8mm | In distribution | |
| G3653530 | In distribution | ||
| G3606074R | 6.0mm | In distribution | |
| 3604516 | 4.5mm x 16mm | In distribution | |
| G3602475 | 3.2/3.5mm to 4.5/4.75mm | In distribution | |
| G3654528 | In distribution | ||
| 360PT3528 | 3.5mm x 28mm | In distribution | |
| G3602513 | 13mm | In distribution | |
| 3654038 | In distribution | ||
| 3654020 | In distribution | ||
| 365PT4030 | In distribution | ||
| 3602525 | SMALL (24mm-30mm) | In distribution | |
| G3602510 | 10mm | In distribution | |
| 3600300 | REGULAR | In distribution | |
| 3654036 | In distribution | ||
| 3604540 | 4.5mm x 40mm | In distribution | |
| G3654042 | In distribution | ||
| 3603012 | 3.0mm x 12mm | In distribution | |
| G3604538 | 4.5mm x 38mm | In distribution | |
| 3607086 | In distribution | ||
| 3654540 | In distribution | ||
| G3654534 | In distribution | ||
| 3653524 | In distribution | ||
| 3603024 | 3.0mm x 24mm | In distribution | |
| G3654020 | In distribution | ||
| G3653534 | In distribution | ||
| 3607003 | In distribution | ||
| G3604540 | 4.5mm x 40mm | In distribution | |
| G365PT3528 | In distribution | ||
| G3650315 | In distribution | ||
| G360PT4022 | 4.0mm x 22mm | In distribution | |
| 3602240 | 3.2mm x 240mm | In distribution | |
| 36537065 | In distribution | ||
| G36537110 | In distribution | ||
| G365PT4020 | In distribution | ||
| 36537110 | In distribution | ||
| 3607066 | In distribution | ||
| 3653514 | In distribution | ||
| 3603014 | 3.0mm x 14mm | In distribution | |
| 3601550 | 3.2/3.5mm to 5.5/6.0mm | In distribution | |
| G3654034 | In distribution | ||
| 365PT4026 | In distribution | ||
| 3602120 | 3.2mm x 120mm | In distribution | |
| G3655525 | In distribution | ||
| G3601519 | 19mm | In distribution | |
| 3654528 | In distribution | ||
| 360T0406 | 4.5mm x 6mm | In distribution | |
| 365PT3540 | In distribution | ||
| 36537100 | In distribution | ||
| 3655530 | In distribution | ||
| 360T0414 | 4.5mm x 14mm | In distribution | |
| G3654024 | In distribution | ||
| G3654022 | In distribution | ||
| G3604036 | 4.0mm x 36mm | In distribution | |
| G3654532 | In distribution | ||
| G365PT3520 | In distribution | ||
| 3653528 | In distribution | ||
| 3603526 | 3.5mm x 26mm | In distribution | |
| G365PT3540 | In distribution | ||
| 3654040 | In distribution | ||
| 3604532 | 4.5mm x 32mm | In distribution | |
| 360T0410 | 4.5mm x 10mm | In distribution | |
| 360PT3530 | 3.5mm x 30mm | In distribution | |
| G3650317 | 4 | In distribution | |
| 360PT3518 | 3.5mm x 18mm | In distribution | |
| G365PT4036 | In distribution | ||
| 365PT4036 | In distribution | ||
| 3654542 | In distribution | ||
| G36535070 | In distribution | ||
| G3654032 | In distribution | ||
| 365PT4038 | In distribution | ||
| 365PT3518 | In distribution | ||
| G3600600 | SMALL | In distribution | |
| G3601550 | 3.2/3.5mm to 5.5/6.0mm | In distribution | |
| G3601475 | 3.2/3.5mm to 4.5/4.75mm | In distribution | |
| 3654538 | In distribution | ||
| 3601519 | 19mm | In distribution | |
| G3655540 | In distribution | ||
| G3603028 | 3.0mm x 28mm | In distribution | |
| 3654522 | In distribution | ||
| G3600508 | 5.0mm x 8mm | In distribution | |
| 3600510 | 5.0mm x 10mm | In distribution | |
| 3655515 | In distribution | ||
| G3654538 | In distribution | ||
| G3602550 | 3.2/3.5mm to 5.5/6.0mm | In distribution | |
| 3607018 | In distribution | ||
| 3600514 | 5.0mm x 14mm | In distribution | |
| 3603538 | 3.5mm x 38mm | In distribution | |
| 365PT3526 | In distribution | ||
| 3607006 | In distribution | ||
| G3604024 | 4.0mm x 24mm | In distribution | |
| 3654042 | In distribution | ||
| 3603522 | 3.5mm x 22mm | In distribution | |
| G365PT3538 | In distribution | ||
| G3654542 | In distribution | ||
| G3604528 | 4.5mm x 28mm | In distribution | |
| 3607029 | In distribution | ||
| 3653508 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bridalveil | Astura Medical | 1,718 |
| Proficient™ Posterior Cervical Spine System | Spine Wave, Inc. | 1,590 |
| Invictus | Alphatec Spine, Inc. | 1,538 |
| Paeon Posterior Cervical Fixation System | Aegis Spine | 1,408 |
| ReLine | Nuvasive, Inc. | 1,072 |
| PathLoc-C Posterior Cervical Fixation System | L&K Biomed Co., Ltd. | 706 |
| Cosy | Signus Medizintechnik Gmbh | 550 |
| Yukon OCT Spinal System | VB Spine LLC | 451 |
| Astra-OCT Spine System | Spinecraft LLC | 440 |
| Symphony | Medos International Sàrl | 389 |
| Medyssey Poseidon OCT Spinal Fixation System | Medyssey Co., Ltd. | 387 |
| Perla ® | Spineart SA | 349 |
Showing 12 of 336. All products under Posterior Cervical Screw System
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.