Quartex
QUARTEX 3.2-4.0 to CREO Threaded 5.5-6.0, Narrow Offset, Dual Headed Adapter
4manufacturers in China registered for this device type
260catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Globus Medical, Inc., United States |
|---|---|
| FDA product code | NKG |
| Device type | Posterior Cervical Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3075 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K161591 |
| Record published | 2019-11-15 |
| Record revised | 2025-07-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
| Sizes | Length 8 to 500 mm; outer diameter 3.5 to 6.5 mm; lumen/inner diameter 3.5 to 5.5 mm; angle 115 to 130 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1149.4522 | Outer Diameter 4.5 mm | In distribution |
| 1149.4138 | Length 38 mm | In distribution |
| 1149.6538 | Outer Diameter 6.5 mm | In distribution |
| 1149.7464 | Length 500 mm | In distribution |
| 1149.3546 | Length 46 mm | In distribution |
| 1149.8527 | In distribution | |
| 1149.3724 | Length 24 mm | In distribution |
| 1149.7080 | Length 80 mm | In distribution |
| 1149.4036 | Outer Diameter 4 mm | In distribution |
| 1149.7250 | Length 500 mm | In distribution |
| 1149.4448 | In distribution | |
| 1149.3544 | Outer Diameter 3.5 mm | In distribution |
| 1149.3512 | Outer Diameter 3.5 mm | In distribution |
| 1149.4822 | In distribution | |
| 1149.4616 | Length 16 mm | In distribution |
| 1149.4038 | Outer Diameter 4 mm | In distribution |
| 1149.8526 | In distribution | |
| 1149.5044 | Outer Diameter 5 mm | In distribution |
| 1149.4240 | Outer Diameter 4 mm | In distribution |
| 1149.8572 | In distribution | |
| 1149.8059 | Length 30 mm | In distribution |
| 1149.1901 | In distribution | |
| 6149.3040 | In distribution | |
| 1149.3614 | Length 14 mm | In distribution |
| 1149.4724 | Length 24 mm | In distribution |
| 1149.4246 | Outer Diameter 4 mm | In distribution |
| 1149.4638 | Length 38 mm | In distribution |
| 1149.3620 | Length 20 mm | In distribution |
| 1149.8070 | In distribution | |
| 1149.4510 | Length 10 mm | In distribution |
| 1149.4540 | Length 40 mm | In distribution |
| 1149.4840 | In distribution | |
| 1149.7620 | Length 120 mm | In distribution |
| 1149.7565 | Length 65 mm | In distribution |
| 1149.8058 | Length 30 mm | In distribution |
| 1149.5024 | Length 24 mm | In distribution |
| 1149.3634 | Outer Diameter 3.5 mm | In distribution |
| 1149.4516 | Outer Diameter 4.5 mm | In distribution |
| 1149.4010 | Outer Diameter 4 mm | In distribution |
| 7149.7620 | Length 120 mm | In distribution |
| 1149.4524 | Outer Diameter 4.5 mm | In distribution |
| 1149.6532 | Length 32 mm | In distribution |
| 1149.4830 | In distribution | |
| 1149.6040 | Outer Diameter 6 mm | In distribution |
| 1149.4144 | Length 44 mm | In distribution |
| 1149.9512 | Length 22.5 mm | In distribution |
| 1149.3542 | Outer Diameter 3.5 mm | In distribution |
| 1149.4622 | Outer Diameter 4.5 mm | In distribution |
| 1149.4134 | Length 34 mm | In distribution |
| 1149.3636 | Length 36 mm | In distribution |
| 1149.8534 | In distribution | |
| 1149.8500 | In distribution | |
| 1149.3548 | Outer Diameter 3.5 mm | In distribution |
| 6149.8002 | In distribution | |
| 1149.6020 | Length 20 mm | In distribution |
| 1149.8513 | In distribution | |
| 1149.9621 | Length 18.3 mm | In distribution |
| 1149.8505 | In distribution | |
| 1149.4848 | In distribution | |
| 1149.8301 | Length 27 mm | In distribution |
| 1149.5020 | Outer Diameter 5 mm | In distribution |
| 1149.8051 | Length 20 mm | In distribution |
| 1149.8580 | In distribution | |
| 1149.8511 | In distribution | |
| 1149.3622 | Outer Diameter 3.5 mm | In distribution |
| 1149.4514 | Length 14 mm | In distribution |
| 1149.3550 | Outer Diameter 3.5 mm | In distribution |
| 1149.4746 | Length 46 mm | In distribution |
| 1149.3730 | Length 30 mm | In distribution |
| 1149.8563 | In distribution | |
| 1149.8524 | In distribution | |
| 1149.5034 | Outer Diameter 5 mm | In distribution |
| 1149.0002 | In distribution | |
| 1149.4838 | In distribution | |
| 1149.6540 | Outer Diameter 6.5 mm | In distribution |
| 1149.3608 | Outer Diameter 3.5 mm | In distribution |
| 1149.4142 | Length 42 mm | In distribution |
| 7149.7535 | Length 35 mm | In distribution |
| 1149.3642 | Length 42 mm | In distribution |
| 1149.8541 | In distribution | |
| 1149.8306 | Length 57 mm | In distribution |
| 1149.8544 | In distribution | |
| 6149.2001 | In distribution | |
| 1149.9531 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1149.6036 | Outer Diameter 6 mm | In distribution |
| 1149.8204 | Length 45 mm | In distribution |
| 6149.6250 | In distribution | |
| 1149.3518 | Length 18 mm | In distribution |
| 1149.5538 | Length 38 mm | In distribution |
| 1149.8581 | In distribution | |
| 1149.7580 | Length 80 mm | In distribution |
| 7149.7462 | Outer Diameter 5 mm | In distribution |
| 1149.4050 | Outer Diameter 4 mm | In distribution |
| 1149.4732 | Length 32 mm | In distribution |
| 1149.4744 | Length 44 mm | In distribution |
| 1149.7545 | Length 45 mm | In distribution |
| 1149.7461 | Outer Diameter 4.75 mm | In distribution |
| 1149.6034 | Outer Diameter 6 mm | In distribution |
| 1149.5524 | Length 24 mm | In distribution |
| 1149.8525 | In distribution | |
| 1149.8101 | Length 27 mm | In distribution |
| 1149.8571 | In distribution | |
| 1149.6044 | Length 44 mm | In distribution |
| 1149.4244 | Outer Diameter 4 mm | In distribution |
| 1149.6526 | Length 26 mm | In distribution |
| 1149.8305 | Length 51 mm | In distribution |
| 1149.4016 | Outer Diameter 4 mm | In distribution |
| 1149.5550 | Outer Diameter 5.5 mm | In distribution |
| 1149.9120 | Length 20 mm | In distribution |
| 1149.4018 | Length 18 mm | In distribution |
| 1149.8529 | In distribution | |
| 1149.4136 | Length 36 mm | In distribution |
| 1149.4140 | Outer Diameter 4 mm | In distribution |
| 1149.3734 | Length 34 mm | In distribution |
| 1149.4824 | In distribution | |
| 1149.1900 | In distribution | |
| 1149.4028 | Length 28 mm | In distribution |
| 1149.3644 | Outer Diameter 3.5 mm | In distribution |
| 1149.7530 | Length 30 mm | In distribution |
| 1149.4612 | Outer Diameter 4.5 mm | In distribution |
| 7149.7545 | Length 45 mm | In distribution |
| 7149.7525 | Length 25 mm | In distribution |
| 1149.4110 | Outer Diameter 4 mm | In distribution |
| 1149.7467 | Outer Diameter 6.5 mm | In distribution |
| 1149.4628 | Outer Diameter 4.5 mm | In distribution |
| 1149.6038 | Outer Diameter 6 mm | In distribution |
| 1149.4032 | Outer Diameter 4 mm | In distribution |
| 7149.7460 | Length 350 mm | In distribution |
| 1149.3508 | Length 8 mm | In distribution |
| 1149.8600 | In distribution | |
| 1149.4550 | Length 50 mm | In distribution |
| 1149.8584 | In distribution | |
| 1149.8001 | Lumen/Inner Diameter 4.5 mm | In distribution |
| 1149.8002 | Lumen/Inner Diameter 4.75 mm | In distribution |
| 1149.8060 | Length 15 mm | In distribution |
| 6149.8020 | In distribution | |
| 1149.0001 | In distribution | |
| 1149.8532 | In distribution | |
| 1149.7465 | Length 350 mm | In distribution |
| 1149.6032 | Outer Diameter 6 mm | In distribution |
| 1149.3740 | Length 40 mm | In distribution |
| 1149.8504 | In distribution | |
| 1149.8530 | In distribution | |
| 1149.4030 | Outer Diameter 4 mm | In distribution |
| 1149.8522 | In distribution | |
| 1149.4720 | Length 20 mm | In distribution |
| 1149.9611 | Length 18.3 mm | In distribution |
| 1149.3510 | Outer Diameter 3.5 mm | In distribution |
| 1149.5042 | Length 42 mm | In distribution |
| 7149.7580 | Length 80 mm | In distribution |
| 1149.9315 | Angle 115 ° | In distribution |
| 1149.8565 | In distribution | |
| 1149.7466 | Outer Diameter 6.35 mm | In distribution |
| 6149.8010 | In distribution | |
| 1149.4442 | In distribution | |
| 1149.4248 | Length 48 mm | In distribution |
| 1149.8057 | Length 20 mm | In distribution |
| 1149.4530 | Outer Diameter 4.5 mm | In distribution |
| 1149.4112 | Outer Diameter 4 mm | In distribution |
| 1149.8073 | In distribution | |
| 1149.8004 | Lumen/Inner Diameter 5.5 mm | In distribution |
| 7149.7040 | Length 40 mm | In distribution |
| 7149.7467 | Length 350 mm | In distribution |
| 1149.8206 | Length 57 mm | In distribution |
| 1149.3726 | Length 26 mm | In distribution |
| 1149.8061 | Length 20 mm | In distribution |
| 1149.8583 | In distribution | |
| 1149.8501 | In distribution | |
| 1149.4630 | Outer Diameter 4.5 mm | In distribution |
| 1149.3516 | Outer Diameter 3.5 mm | In distribution |
| 1149.3738 | Outer Diameter 3.5 mm | In distribution |
| 1149.9330 | Angle 130 ° | In distribution |
| 1149.6536 | Length 36 mm | In distribution |
| 1149.8072 | In distribution | |
| 1149.8528 | In distribution | |
| 1149.9522 | Length 22.5 mm | In distribution |
| 1149.8537 | In distribution | |
| 1149.4428 | In distribution | |
| 1149.4734 | Length 34 mm | In distribution |
| 1149.8102 | Length 33 mm | In distribution |
| 1149.7525 | Length 25 mm | In distribution |
| 1149.8602 | In distribution | |
| 1149.8538 | In distribution | |
| 1149.4242 | Outer Diameter 4 mm | In distribution |
| 1149.8201 | Length 27 mm | In distribution |
| 1149.7460 | Outer Diameter 4.5 mm | In distribution |
| 1149.4426 | In distribution | |
| 7149.9330 | Angle 130 ° | In distribution |
| 1149.3514 | Length 14 mm | In distribution |
| 1149.4546 | Length 46 mm | In distribution |
| 7149.7565 | Length 65 mm | In distribution |
| 1149.4642 | Outer Diameter 4.5 mm | In distribution |
| 1149.9632 | Lumen/Inner Diameter 4 mm | In distribution |
| 1149.4716 | Length 16 mm | In distribution |
| 1149.9112 | Outer Diameter 4.6 mm | In distribution |
| 7149.7585 | Length 85 mm | In distribution |
| 1149.5542 | Length 42 mm | In distribution |
| 1149.5548 | Outer Diameter 5.5 mm | In distribution |
| 1149.9110 | Outer Diameter 4.6 mm | In distribution |
| 1149.4842 | In distribution | |
| 1149.9118 | Outer Diameter 4.6 mm | In distribution |
| 1149.4430 | In distribution | |
| 1149.4542 | Outer Diameter 4.5 mm | In distribution |
| 1149.4740 | Length 40 mm | In distribution |
| 1149.5530 | Outer Diameter 5.5 mm | In distribution |
| 1149.3736 | Outer Diameter 3.5 mm | In distribution |
| 1149.6528 | Outer Diameter 6.5 mm | In distribution |
| 1149.4538 | Outer Diameter 4.5 mm | In distribution |
| 1149.6546 | Outer Diameter 6.5 mm | In distribution |
| 1149.5032 | Length 32 mm | In distribution |
| 1149.4836 | In distribution | |
| 1149.4846 | In distribution | |
| 1149.4544 | Outer Diameter 4.5 mm | In distribution |
| 1149.7040 | Length 40 mm | In distribution |
| 1149.3746 | Outer Diameter 3.5 mm | In distribution |
| 1149.7595 | Length 95 mm | In distribution |
| 1149.4450 | In distribution | |
| 1149.9020 | Outer Diameter 4.2 mm | In distribution |
| 1149.8000 | Lumen/Inner Diameter 4 mm | In distribution |
| 1149.4124 | Outer Diameter 4 mm | In distribution |
| 1149.4234 | Outer Diameter 4 mm | In distribution |
| 1149.4632 | Outer Diameter 4.5 mm | In distribution |
| 1149.9511 | Length 17.5 mm | In distribution |
| 1149.4834 | In distribution | |
| 7149.7120 | Length 120 mm | In distribution |
| 1149.4148 | Outer Diameter 4 mm | In distribution |
| 1149.7560 | Length 60 mm | In distribution |
| 1149.8103 | Length 39 mm | In distribution |
| 1149.8202 | Length 33 mm | In distribution |
| 7149.7610 | Length 110 mm | In distribution |
| 1149.4224 | Length 24 mm | In distribution |
| 1149.4818 | In distribution | |
| 1149.4826 | In distribution | |
| 1149.6542 | Outer Diameter 6.5 mm | In distribution |
| 1149.8562 | In distribution | |
| 1149.9018 | Outer Diameter 4.2 mm | In distribution |
| 1149.8205 | Length 51 mm | In distribution |
| 1149.4636 | Outer Diameter 4.5 mm | In distribution |
| 1149.4712 | Length 12 mm | In distribution |
| 1149.4710 | Length 10 mm | In distribution |
| 1149.7575 | Length 75 mm | In distribution |
| 1149.4644 | Length 44 mm | In distribution |
| 1149.7540 | Length 40 mm | In distribution |
| 1149.9210 | Length 24 mm | In distribution |
| 1149.8545 | In distribution | |
| 1149.3530 | Length 30 mm | In distribution |
| 1149.3722 | Outer Diameter 3.5 mm | In distribution |
| 1149.4238 | Length 38 mm | In distribution |
| 1149.5026 | Length 26 mm | In distribution |
| 1149.6548 | Outer Diameter 6.5 mm | In distribution |
Showing 250 of 260 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 |
| Infinity™ Occipitocervical Upper Thoracic System | Medtronic Sofamor Danek, Inc. | 375 |
Showing 12 of 336. All products under Posterior Cervical Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231850 | 2024-03-14 |
| K211957 | 2021-08-18 |
| K161591 | 2016-09-21 |
| K150552 | 2015-06-04 |
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.