Quartex
QUARTEX 3.2-4.0 to CREO Threaded 5.5-6.0, Double, Dual Headed Inline Adapter
11manufacturers in China registered for this device type
254catalogue numbers in this listing
7510(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 | Globus Medical, Inc., United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K161591 |
| Record published | 2019-11-12 |
| 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 6 to 500 mm; outer diameter 3.5 to 6.5 mm; lumen/inner diameter 3.5 to 6.5 mm; angle 100 to 115 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1149.3524 | Outer Diameter 3.5 mm | In distribution |
| 1149.3616 | Outer Diameter 3.5 mm | In distribution |
| 1149.3646 | Outer Diameter 3.5 mm | In distribution |
| 1149.3624 | Length 24 mm | In distribution |
| 1149.3628 | Outer Diameter 3.5 mm | In distribution |
| 1149.8539 | In distribution | |
| 1149.8071 | In distribution | |
| 1149.8515 | In distribution | |
| 1149.4646 | Length 46 mm | In distribution |
| 1149.4432 | In distribution | |
| 1149.4534 | Length 34 mm | In distribution |
| 1149.4026 | Outer Diameter 4 mm | In distribution |
| 1149.4526 | Outer Diameter 4.5 mm | In distribution |
| 1149.4738 | Length 38 mm | In distribution |
| 1149.5036 | Outer Diameter 5 mm | In distribution |
| 1149.5526 | Outer Diameter 5.5 mm | In distribution |
| 1149.4750 | Length 50 mm | In distribution |
| 7149.7595 | Length 95 mm | In distribution |
| 1149.5046 | Outer Diameter 5 mm | In distribution |
| 1149.8005 | Lumen/Inner Diameter 6 mm | In distribution |
| 1149.8100 | Length 21 mm | In distribution |
| 1149.4118 | Outer Diameter 4 mm | In distribution |
| 1149.8300 | Length 21 mm | In distribution |
| 1149.4620 | Length 20 mm | In distribution |
| 7149.7600 | Length 100 mm | In distribution |
| 1149.4232 | Length 32 mm | In distribution |
| 1149.8006 | Lumen/Inner Diameter 6.35 mm | In distribution |
| 1149.4230 | Length 30 mm | In distribution |
| 1149.9200 | Length 20 mm | In distribution |
| 7149.7560 | Length 60 mm | In distribution |
| 1149.3630 | Outer Diameter 3.5 mm | In distribution |
| 1149.3648 | Outer Diameter 3.5 mm | In distribution |
| 1149.3626 | Outer Diameter 3.5 mm | In distribution |
| 1149.9300 | Angle 100 ° | In distribution |
| 1149.6522 | Length 22 mm | In distribution |
| 1149.8104 | Length 45 mm | In distribution |
| 6149.2305 | In distribution | |
| 1149.5030 | Outer Diameter 5 mm | In distribution |
| 1149.7550 | Length 50 mm | In distribution |
| 1149.8055 | Length 20 mm | In distribution |
| 1149.4114 | Length 14 mm | In distribution |
| 6149.6900 | In distribution | |
| 1149.6026 | Length 26 mm | In distribution |
| 1149.4728 | Length 28 mm | In distribution |
| 1149.4820 | In distribution | |
| 1149.7570 | Length 70 mm | In distribution |
| 1149.5536 | Length 36 mm | In distribution |
| 1149.8062 | Length 15 mm | In distribution |
| 1149.8652 | In distribution | |
| 1149.8585 | In distribution | |
| 1149.6050 | Outer Diameter 6 mm | In distribution |
| 1149.5540 | Outer Diameter 5.5 mm | In distribution |
| 1149.4736 | Length 36 mm | In distribution |
| 1149.4650 | Outer Diameter 4.5 mm | In distribution |
| 1149.3612 | Outer Diameter 3.5 mm | In distribution |
| 1149.8582 | In distribution | |
| 1149.8050 | In distribution | |
| 1149.3526 | Length 26 mm | In distribution |
| 1149.8063 | Length 20 mm | In distribution |
| 1149.8054 | In distribution | |
| 1149.4048 | Length 48 mm | In distribution |
| 1149.8575 | In distribution | |
| 1149.4828 | In distribution | |
| 1149.8053 | Length 20 mm | In distribution |
| 1149.8521 | In distribution | |
| 1149.8052 | Length 9 mm | In distribution |
| 1149.4742 | Length 42 mm | In distribution |
| 1149.6544 | Length 44 mm | In distribution |
| 1149.4614 | Length 14 mm | In distribution |
| 1149.3538 | Outer Diameter 3.5 mm | In distribution |
| 1149.8510 | In distribution | |
| 7149.7615 | Length 115 mm | In distribution |
| 1149.3534 | Length 34 mm | In distribution |
| 1149.6042 | Outer Diameter 6 mm | In distribution |
| 1149.3528 | Outer Diameter 3.5 mm | In distribution |
| 1149.3522 | Length 22 mm | In distribution |
| 1149.4726 | Length 26 mm | In distribution |
| 1149.3744 | Length 44 mm | In distribution |
| 1149.4528 | Length 28 mm | In distribution |
| 1149.4730 | Length 30 mm | In distribution |
| 1149.4150 | Outer Diameter 4 mm | In distribution |
| 1149.4832 | In distribution | |
| 1149.9612 | Length 23.3 mm | In distribution |
| 1149.8535 | In distribution | |
| 7149.7555 | Length 55 mm | In distribution |
| 1149.9532 | Length 22.5 mm | In distribution |
| 1149.8570 | In distribution | |
| 7149.7550 | Length 50 mm | In distribution |
| 1149.8304 | Length 45 mm | In distribution |
| 1149.9008 | Outer Diameter 4.2 mm | In distribution |
| 1149.5040 | Outer Diameter 5 mm | In distribution |
| 1149.4714 | Length 14 mm | In distribution |
| 1149.3732 | Outer Diameter 3.5 mm | In distribution |
| 1149.3750 | Outer Diameter 3.5 mm | In distribution |
| 1149.7462 | Length 350 mm | In distribution |
| 1149.9116 | Outer Diameter 4.6 mm | In distribution |
| 1149.3640 | Outer Diameter 3.5 mm | In distribution |
| 1149.0003 | In distribution | |
| 1149.4532 | Outer Diameter 4.5 mm | In distribution |
| 1149.4116 | Length 16 mm | In distribution |
| 1149.9106 | Outer Diameter 4.6 mm | In distribution |
| 1149.6022 | Outer Diameter 6 mm | In distribution |
| 1149.1902 | In distribution | |
| 1149.6530 | Length 30 mm | In distribution |
| 1149.4718 | Length 18 mm | In distribution |
| 1149.6046 | Outer Diameter 6 mm | In distribution |
| 1149.8056 | Length 9 mm | In distribution |
| 1149.9114 | Outer Diameter 4.6 mm | In distribution |
| 1149.9622 | Lumen/Inner Diameter 4 mm | In distribution |
| 1149.9631 | Length 18.3 mm | In distribution |
| 1149.5050 | Outer Diameter 5 mm | In distribution |
| 7149.7240 | Length 240 mm | In distribution |
| 1149.8564 | In distribution | |
| 1149.4850 | In distribution | |
| 1149.5038 | Outer Diameter 5 mm | In distribution |
| 7149.7463 | Outer Diameter 5.5 mm | In distribution |
| 1149.4014 | Length 14 mm | In distribution |
| 1149.4618 | Outer Diameter 4.5 mm | In distribution |
| 1149.4034 | Length 34 mm | In distribution |
| 1149.4748 | Length 48 mm | In distribution |
| 1149.4042 | Length 42 mm | In distribution |
| 1149.9450 | In distribution | |
| 1149.4440 | In distribution | |
| 1149.8200 | Length 21 mm | In distribution |
| 1149.4812 | In distribution | |
| 1149.6520 | Length 20 mm | In distribution |
| 7149.7605 | Length 105 mm | In distribution |
| 1149.6550 | Length 50 mm | In distribution |
| 1149.4128 | Length 28 mm | In distribution |
| 1149.4810 | In distribution | |
| 1149.7240 | Length 240 mm | In distribution |
| 1149.9012 | Length 12 mm | In distribution |
| 1149.8007 | Lumen/Inner Diameter 6.5 mm | In distribution |
| 7149.7250 | Length 500 mm | In distribution |
| 1149.4422 | In distribution | |
| 7149.7570 | Length 70 mm | In distribution |
| 1149.5028 | Length 28 mm | In distribution |
| 1149.4132 | Outer Diameter 4 mm | In distribution |
| 1149.8003 | Lumen/Inner Diameter 5 mm | In distribution |
| 1149.4236 | Outer Diameter 4 mm | In distribution |
| 1149.6048 | Outer Diameter 6 mm | In distribution |
| 1149.3540 | Length 40 mm | In distribution |
| 1149.8302 | Length 33 mm | In distribution |
| 7149.7080 | Length 80 mm | In distribution |
| 6149.3250 | In distribution | |
| 1149.7585 | Length 85 mm | In distribution |
| 7149.7465 | Outer Diameter 6 mm | In distribution |
| 1149.8520 | In distribution | |
| 1149.4816 | In distribution | |
| 1149.8531 | In distribution | |
| 1149.7610 | Length 110 mm | In distribution |
| 1149.8651 | In distribution | |
| 7149.7466 | Outer Diameter 6.35 mm | In distribution |
| 1149.7120 | Length 120 mm | In distribution |
| 1149.4722 | Length 22 mm | In distribution |
| 1149.4640 | Length 40 mm | In distribution |
| 1149.8574 | In distribution | |
| 1149.7535 | Length 35 mm | In distribution |
| 1149.9016 | Outer Diameter 4.2 mm | In distribution |
| 1149.3728 | Outer Diameter 3.5 mm | In distribution |
| 1149.4634 | Length 34 mm | In distribution |
| 1149.4444 | In distribution | |
| 7149.7461 | Length 350 mm | In distribution |
| 1149.3638 | Length 38 mm | In distribution |
| 1149.4610 | Length 10 mm | In distribution |
| 7149.9315 | Angle 115 ° | In distribution |
| 6149.2005 | In distribution | |
| 1149.5520 | Outer Diameter 5.5 mm | In distribution |
| 6149.3240 | In distribution | |
| 1149.8560 | In distribution | |
| 1149.3632 | Outer Diameter 3.5 mm | In distribution |
| 1149.8533 | In distribution | |
| 1149.8653 | In distribution | |
| 1149.9006 | Outer Diameter 4.2 mm | In distribution |
| 1149.7555 | Length 55 mm | In distribution |
| 1149.5022 | Length 22 mm | In distribution |
| 1149.3536 | Length 36 mm | In distribution |
| 1149.7605 | Length 105 mm | In distribution |
| 1149.3742 | Length 42 mm | In distribution |
| 1149.8536 | In distribution | |
| 1149.6534 | Length 34 mm | In distribution |
| 1149.4424 | In distribution | |
| 1149.3520 | Length 20 mm | In distribution |
| 1149.9455 | In distribution | |
| 1149.8502 | In distribution | |
| 1149.7600 | Length 100 mm | In distribution |
| 1149.8303 | Length 39 mm | In distribution |
| 1149.4024 | Length 24 mm | In distribution |
| 1149.4012 | Outer Diameter 4 mm | In distribution |
| 6149.6910 | In distribution | |
| 1149.4250 | Length 50 mm | In distribution |
| 1149.6524 | Length 24 mm | In distribution |
| 1149.4446 | In distribution | |
| 1149.4022 | Length 22 mm | In distribution |
| 1149.9521 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 1149.5048 | Outer Diameter 5 mm | In distribution |
| 1149.4040 | Length 40 mm | In distribution |
| 1149.4512 | Outer Diameter 4.5 mm | In distribution |
| 1149.3618 | Length 18 mm | In distribution |
| 1149.4626 | Outer Diameter 4.5 mm | In distribution |
| 1149.8654 | In distribution | |
| 1149.8514 | In distribution | |
| 1149.4814 | In distribution | |
| 7149.7590 | Length 90 mm | In distribution |
| 1149.8561 | In distribution | |
| 1149.4438 | In distribution | |
| 1149.4518 | Outer Diameter 4.5 mm | In distribution |
| 1149.8655 | In distribution | |
| 1149.8512 | In distribution | |
| 1149.3748 | Length 48 mm | In distribution |
| 1149.5544 | Outer Diameter 5.5 mm | In distribution |
| 1149.4436 | In distribution | |
| 1149.3532 | Outer Diameter 3.5 mm | In distribution |
| 1149.4222 | Outer Diameter 4 mm | In distribution |
| 1149.4434 | In distribution | |
| 1149.5534 | Length 34 mm | In distribution |
| 1149.4844 | In distribution | |
| 7149.7575 | Length 75 mm | In distribution |
| 7149.7464 | Length 500 mm | In distribution |
| 1149.8106 | Length 57 mm | In distribution |
| 1149.4122 | Outer Diameter 4 mm | In distribution |
| 1149.4536 | Length 36 mm | In distribution |
| 1149.7463 | Length 350 mm | In distribution |
| 1149.6030 | Length 30 mm | In distribution |
| 7149.7530 | Length 30 mm | In distribution |
| 1149.4130 | Outer Diameter 4 mm | In distribution |
| 1149.8203 | Length 39 mm | In distribution |
| 6149.3220 | In distribution | |
| 1149.9108 | Length 8 mm | In distribution |
| 1149.4146 | Length 46 mm | In distribution |
| 1149.4226 | Outer Diameter 4 mm | In distribution |
| 1149.6024 | Length 24 mm | In distribution |
| 1149.6028 | Outer Diameter 6 mm | In distribution |
| 6149.3200 | In distribution | |
| 7149.9300 | Angle 100 ° | In distribution |
| 1149.4046 | Length 46 mm | In distribution |
| 1149.4044 | Length 44 mm | In distribution |
| 1149.8105 | Length 51 mm | In distribution |
| 1149.8573 | In distribution | |
| 1149.9014 | Outer Diameter 4.2 mm | In distribution |
| 1149.8523 | In distribution | |
| 1149.4520 | Outer Diameter 4.5 mm | In distribution |
| 6149.8000 | In distribution | |
| 1149.4548 | Outer Diameter 4.5 mm | In distribution |
| 1149.7590 | Length 90 mm | In distribution |
| 6149.2000 | In distribution | |
| 1149.4020 | Outer Diameter 4 mm | In distribution |
| 1149.4120 | Length 20 mm | In distribution |
| 1149.4624 | Length 24 mm | In distribution |
| 7149.7540 | Length 40 mm | In distribution |
Showing 250 of 254 catalogue numbers.
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 |
|---|---|
| K123783 | 2013-03-14 |
| K110963 | 2011-05-05 |
| K102195 | 2011-01-19 |
| K090565 | 2009-06-30 |
| K081906 | 2008-11-14 |
| K052069 | 2005-08-17 |
| K050391 | 2005-07-21 |
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.