Captivate
CAPTIVATE Sola Headless Compression Screw, 2.5x13mm, Short Thread, Ti
31manufacturers in China registered for this device type
1,247catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K162825 |
| Record published | 2022-12-08 |
| Record revised | 2024-02-19 (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, expiry date |
| Sizes | Outer diameter 2.5 to 13 mm; length 9 to 180 mm; lumen/inner diameter 4 to 7.5 mm; height 1.25 to 1.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1178.3520 | In distribution | |
| 2178.6562 | (32mm thread) | In distribution |
| 1178.6581 | (16mm thread) | In distribution |
| 2178.6610 | Length 110 mm | In distribution |
| 2178.2926 | In distribution | |
| 1188.3210 | Length 10 mm | In distribution |
| 1178.6541 | Outer Diameter 6.5 mm | In distribution |
| 1178.7645 | fully threaded | In distribution |
| 2178.4442 | Length 42 mm | In distribution |
| 2178.3548 | In distribution | |
| 2188.2924 | Length 24 mm | In distribution |
| 1178.7611 | Length 110 mm | In distribution |
| 1178.3210 | In distribution | |
| 1178.4020 | In distribution | |
| 1178.6602 | Length 100 mm | In distribution |
| 2178.5580 | In distribution | |
| 2178.6577 | Outer Diameter 6.5 mm | In distribution |
| 2178.3750 | In distribution | |
| 2178.4034 | In distribution | |
| 2178.5575 | In distribution | |
| 2178.6626 | Outer Diameter 6.5 mm | In distribution |
| 1178.6590 | Length 90 mm | In distribution |
| 2188.4244 | Outer Diameter 4 mm | In distribution |
| 2178.7635 | fully threaded | In distribution |
| 1178.3746 | In distribution | |
| 2178.7572 | Length 70 mm | In distribution |
| 1188.4434 | Length 34 mm | In distribution |
| 1178.7546 | (16mm thread) | In distribution |
| 2178.3424 | In distribution | |
| 2178.4100 | In distribution | |
| 2178.4480 | long thread | In distribution |
| 6188.6230 | Bone Thread Diameter 3.0mm | In distribution |
| 2188.3219 | short thread | In distribution |
| 2178.6585 | fully threaded | In distribution |
| 2178.6565 | Outer Diameter 6.5 mm | In distribution |
| 2178.4432 | long thread | In distribution |
| 1178.2910 | In distribution | |
| 1178.3444 | In distribution | |
| 2178.5590 | In distribution | |
| 1178.3244 | In distribution | |
| 1178.2717 | In distribution | |
| 1188.3211 | short thread | In distribution |
| 2188.2923 | Outer Diameter 2.5 mm | In distribution |
| 1178.6596 | Outer Diameter 6.5 mm | In distribution |
| 2178.4800 | In distribution | |
| 3188.3119 | Length 19.0 mm | In distribution |
| 2178.4455 | Outer Diameter 4 mm | In distribution |
| 2188.2713 | short thread | In distribution |
| 2178.3746 | In distribution | |
| 2178.4475 | Outer Diameter 4 mm | In distribution |
| 1178.7631 | Outer Diameter 7.5 mm | In distribution |
| 2178.4744 | In distribution | |
| 1188.2718 | Length 18 mm | In distribution |
| 2178.7620 | Length 120 mm | In distribution |
| 2178.3526 | In distribution | |
| 2188.3217 | short thread | In distribution |
| 1178.3422 | In distribution | |
| 2178.7617 | Length 115 mm | In distribution |
| 1178.5740 | In distribution | |
| 1188.4444 | Outer Diameter 4 mm | In distribution |
| 2178.6586 | Outer Diameter 6.5 mm | In distribution |
| 2178.4040 | In distribution | |
| 1178.3516 | In distribution | |
| 2178.7647 | (32mm thread) | In distribution |
| 1178.7647 | Outer Diameter 7.5 mm | In distribution |
| 2178.5605 | In distribution | |
| 1178.2736 | In distribution | |
| 2178.4438 | long thread | In distribution |
| 2178.7610 | Outer Diameter 7.5 mm | In distribution |
| 2178.6607 | Outer Diameter 6.5 mm | In distribution |
| 2188.3240 | short thread | In distribution |
| 2188.4440 | Length 40 mm | In distribution |
| 2188.4436 | Length 36 mm | In distribution |
| 2178.3220 | In distribution | |
| 2178.3420 | In distribution | |
| 1178.4244 | In distribution | |
| 2178.2940 | In distribution | |
| 2188.2730 | short thread | In distribution |
| 2178.3765 | In distribution | |
| 2178.4070 | In distribution | |
| 1188.4248 | Length 48 mm | In distribution |
| 2178.5542 | In distribution | |
| 2178.4734 | In distribution | |
| 3188.2513 | Short Thread | In distribution |
| 2188.3223 | Outer Diameter 3 mm | In distribution |
| 1178.5750 | In distribution | |
| 1188.4232 | Outer Diameter 4 mm | In distribution |
| 1178.4540 | In distribution | |
| 2178.2914 | In distribution | |
| 2178.5800 | In distribution | |
| 2178.4434 | Length 34 mm | In distribution |
| 2178.4536 | In distribution | |
| 2178.4470 | Length 70 mm | In distribution |
| 1188.3417 | Outer Diameter 3 mm | In distribution |
| 2178.3436 | In distribution | |
| 1178.7627 | Outer Diameter 7.5 mm | In distribution |
| 1178.4775 | In distribution | |
| 1178.2915 | In distribution | |
| 1178.3726 | In distribution | |
| 1178.3524 | In distribution | |
| 2178.6645 | Outer Diameter 6.5 mm | In distribution |
| 2178.6636 | Length 135 mm | In distribution |
| 2178.6641 | Length 140 mm | In distribution |
| 2178.7660 | Outer Diameter 7.5 mm | In distribution |
| 1178.7551 | Length 50 mm | In distribution |
| 6188.6240 | Bone Thread Diameter 4.0mm | In distribution |
| 1178.6601 | Length 100 mm | In distribution |
| 1178.7607 | Length 105 mm | In distribution |
| 1188.2917 | long thread | In distribution |
| 2178.6627 | Outer Diameter 6.5 mm | In distribution |
| 1178.4760 | In distribution | |
| 1178.5955 | In distribution | |
| 2178.2915 | In distribution | |
| 1178.7621 | Outer Diameter 7.5 mm | In distribution |
| 2188.3232 | Outer Diameter 3 mm | In distribution |
| 2178.7582 | Outer Diameter 7.5 mm | In distribution |
| 2178.6612 | (32mm thread) | In distribution |
| 1178.4046 | In distribution | |
| 1178.5785 | In distribution | |
| 3188.2616 | Outer Diameter 2.5 mm | In distribution |
| 1178.6650 | fully threaded | In distribution |
| 2178.6646 | Outer Diameter 6.5 mm | In distribution |
| 3188.2617 | Length 17.0 mm | In distribution |
| 4188.3118 | Long Thread | In distribution |
| 2178.4022 | In distribution | |
| 1188.3426 | long thread | In distribution |
| 1188.3419 | Outer Diameter 3 mm | In distribution |
| 1188.3423 | Length 23 mm | In distribution |
| 4188.3011 | Length 11.0 mm | In distribution |
| 4188.2511 | Length 11.0 mm | In distribution |
| 1188.4452 | Outer Diameter 4 mm | In distribution |
| 1188.4216 | Outer Diameter 4 mm | In distribution |
| 2178.6632 | Length 130 mm | In distribution |
| 1188.4228 | Length 28 mm | In distribution |
| 2178.7545 | Outer Diameter 7.5 mm | In distribution |
| 2178.4232 | In distribution | |
| 1178.6577 | (32mm thread) | In distribution |
| 1178.6617 | Outer Diameter 6.5 mm | In distribution |
| 2188.2738 | Length 38 mm | In distribution |
| 1178.6605 | fully threaded | In distribution |
| 2178.3546 | In distribution | |
| 1178.3536 | In distribution | |
| 1178.7545 | Length 45 mm | In distribution |
| 2178.4550 | In distribution | |
| 1178.0175 | No Suture Holes | In distribution |
| 2178.4426 | long thread | In distribution |
| 2178.6622 | Outer Diameter 6.5 mm | In distribution |
| 1178.5600 | In distribution | |
| 1178.3546 | In distribution | |
| 2178.4565 | In distribution | |
| 2188.3225 | Outer Diameter 3 mm | In distribution |
| 1178.3419 | In distribution | |
| 1178.4534 | In distribution | |
| 1188.2923 | Outer Diameter 2.5 mm | In distribution |
| 1178.7571 | Length 70 mm | In distribution |
| 2178.6617 | Outer Diameter 6.5 mm | In distribution |
| 1178.6565 | Outer Diameter 6.5 mm | In distribution |
| 2188.4458 | Outer Diameter 4 mm | In distribution |
| 1188.4254 | short thread | In distribution |
| 2178.7632 | Outer Diameter 7.5 mm | In distribution |
| 1188.2938 | Outer Diameter 2.5 mm | In distribution |
| 2178.4046 | In distribution | |
| 1178.4280 | In distribution | |
| 2178.4234 | In distribution | |
| 2178.3426 | In distribution | |
| 2178.7565 | Outer Diameter 7.5 mm | In distribution |
| 1178.4240 | In distribution | |
| 1178.4238 | In distribution | |
| 1178.2914 | In distribution | |
| 2178.5740 | In distribution | |
| 1178.6626 | Length 125 mm | In distribution |
| 1178.2740 | In distribution | |
| 1178.3560 | In distribution | |
| 1178.2728 | In distribution | |
| 2178.3536 | In distribution | |
| 2178.7652 | Length 150 mm | In distribution |
| 1178.4750 | In distribution | |
| 2178.3770 | In distribution | |
| 1188.2927 | Length 27 mm | In distribution |
| 2178.7621 | Length 120 mm | In distribution |
| 1178.7665 | Length 165 mm | In distribution |
| 1178.7660 | Outer Diameter 7.5 mm | In distribution |
| 1178.2926 | In distribution | |
| 1178.6651 | Length 150 mm | In distribution |
| 1178.3246 | In distribution | |
| 1178.3175 | In distribution | |
| 2178.4428 | long thread | In distribution |
| 1188.4246 | Length 46 mm | In distribution |
| 1178.7585 | fully threaded | In distribution |
| 2178.6656 | Length 155 mm | In distribution |
| 2178.7661 | Length 160 mm | In distribution |
| 2178.3236 | In distribution | |
| 2188.4454 | long thread | In distribution |
| 1178.6620 | Length 120 mm | In distribution |
| 2178.6671 | Outer Diameter 6.5 mm | In distribution |
| 2178.6557 | (32mm thread) | In distribution |
| 1188.2924 | long thread | In distribution |
| 1178.6627 | Outer Diameter 6.5 mm | In distribution |
| 1178.2908 | In distribution | |
| 2178.3738 | In distribution | |
| 2178.4795 | In distribution | |
| 2178.2919 | In distribution | |
| 1178.3228 | In distribution | |
| 1178.7575 | Length 75 mm | In distribution |
| 1178.5580 | In distribution | |
| 2178.3522 | In distribution | |
| 1188.2738 | Length 38 mm | In distribution |
| 2188.3234 | Length 34 mm | In distribution |
| 2178.4026 | In distribution | |
| 1178.4565 | In distribution | |
| 2178.6595 | Outer Diameter 6.5 mm | In distribution |
| 1178.6632 | Outer Diameter 6.5 mm | In distribution |
| 1178.7640 | Length 140 mm | In distribution |
| 2188.2917 | Outer Diameter 2.5 mm | In distribution |
| 2178.7650 | Outer Diameter 7.5 mm | In distribution |
| 2188.2929 | long thread | In distribution |
| 1178.4050 | In distribution | |
| 1188.3213 | Length 13 mm | In distribution |
| 1188.4220 | Outer Diameter 4 mm | In distribution |
| 1178.4024 | In distribution | |
| 2178.3444 | In distribution | |
| 1178.5746 | In distribution | |
| 1178.3213 | In distribution | |
| 2188.3224 | Length 24 mm | In distribution |
| 2178.3446 | In distribution | |
| 1178.4455 | Length 55 mm | In distribution |
| 2178.6601 | Length 100 mm | In distribution |
| 1178.4744 | In distribution | |
| 1188.2928 | Length 28 mm | In distribution |
| 2178.6541 | Length 40 mm | In distribution |
| 1178.3730 | In distribution | |
| 1188.4224 | Length 24 mm | In distribution |
| 1178.3570 | In distribution | |
| 1178.6566 | Length 65 mm | In distribution |
| 1178.6587 | Length 85 mm | In distribution |
| 2178.4280 | In distribution | |
| 2178.6670 | fully threaded | In distribution |
| 1178.7550 | Outer Diameter 7.5 mm | In distribution |
| 2178.7657 | (32mm thread) | In distribution |
| 2178.3555 | In distribution | |
| 2178.2734 | In distribution | |
| 2178.6576 | Length 75 mm | In distribution |
| 1178.7556 | Length 55 mm | In distribution |
| 2178.5540 | In distribution | |
| 2178.7577 | (32mm thread) | In distribution |
| 2178.7576 | Outer Diameter 7.5 mm | In distribution |
| 1188.4454 | Length 54 mm | In distribution |
| 2178.7570 | fully threaded | In distribution |
| 2178.4044 | In distribution | |
| 1178.7622 | Outer Diameter 7.5 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222409 | 2022-09-08 |
| K162825 | 2017-05-01 |
| K112028 | 2011-12-09 |
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.