Invictus
POLYAXIAL SCREW, PARTIALLY THREADED, BT, 4.0mm X 52mm
4manufacturers in China registered for this device type
1,538catalogue numbers in this listing
3510(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 | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | NKG |
| Device type | Posterior Cervical Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3075 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K203125 |
| Record published | 2021-02-17 |
| Record revised | 2025-07-14 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 3.5 to 6 mm; length 6 to 600 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 18091-50-14 | Outer Diameter 5 mm | In distribution |
| 18301-45 | In distribution | |
| 18000-35-18 | Length 18 mm | In distribution |
| 19008-40-12 | Outer Diameter 4 mm | In distribution |
| 19028-35-16 | Outer Diameter 3.5 mm | In distribution |
| 19009-40-52 | Length 52 mm | In distribution |
| 19000-35-36 | Length 36 mm | In distribution |
| 19020-45-14 | Length 14 mm | In distribution |
| 19028-40-36 | Length 36 mm | In distribution |
| 18620-50-45 | Outer Diameter 5 mm | In distribution |
| 18620-45-50 | Outer Diameter 4.5 mm | In distribution |
| 18620-35-42 | Outer Diameter 3.5 mm | In distribution |
| 19008-40-46 | Outer Diameter 4 mm | In distribution |
| 18010-35-22 | Outer Diameter 3.5 mm | In distribution |
| 18222-35-55-200 | In distribution | |
| 18620-45-40 | Length 40 mm | In distribution |
| 19008-35-52 | Outer Diameter 3.5 mm | In distribution |
| 19020-55-45 | Length 45 mm | In distribution |
| 19020-35-20 | Length 20 mm | In distribution |
| 18302-40-50 | Outer Diameter 4 mm | In distribution |
| 19003-45-40 | Length 40 mm | In distribution |
| 19003-40-42 | Outer Diameter 4 mm | In distribution |
| 19003-40-56 | Outer Diameter 4 mm | In distribution |
| 18020-45-24 | In distribution | |
| 18620-35-40 | Outer Diameter 3.5 mm | In distribution |
| 18620-45-45 | Outer Diameter 4.5 mm | In distribution |
| 19010-40-12 | Outer Diameter 4 mm | In distribution |
| 19020-35-46 | Outer Diameter 3.5 mm | In distribution |
| 19008-35-30 | Outer Diameter 3.5 mm | In distribution |
| 19028-35-18 | Length 18 mm | In distribution |
| 19000-40-12 | Outer Diameter 4 mm | In distribution |
| 19020-45-26 | Length 26 mm | In distribution |
| 18030-55-60 | Length 60 mm | In distribution |
| 19020-35-14 | Length 14 mm | In distribution |
| 19003-35-44 | Outer Diameter 3.5 mm | In distribution |
| 18200-35-120 | Length 120 mm | In distribution |
| 19028-35-54 | Length 54 mm | In distribution |
| 18000-35-32 | Outer Diameter 3.5 mm | In distribution |
| 19008-50-60 | Length 60 mm | In distribution |
| 18091-50-08 | Outer Diameter 5 mm | In distribution |
| 19018-40-42 | Outer Diameter 4 mm | In distribution |
| 18702-35-40 | Length 40 mm | In distribution |
| 18210-40-060 | Length 60 mm | In distribution |
| 19000-35-26 | Length 26 mm | In distribution |
| 19010-35-10 | Outer Diameter 3.5 mm | In distribution |
| 19009-45-58 | Length 58 mm | In distribution |
| 18030-35-40 | Outer Diameter 3.5 mm | In distribution |
| 19003-35-36 | Outer Diameter 3.5 mm | In distribution |
| 18610-55-35 | Length 35 mm | In distribution |
| 19020-35-16 | Length 16 mm | In distribution |
| 19028-40-18 | Length 18 mm | In distribution |
| 19008-35-08 | Length 8 mm | In distribution |
| 19000-40-50 | Length 50 mm | In distribution |
| 19028-35-44 | Outer Diameter 3.5 mm | In distribution |
| 19008-40-52 | Outer Diameter 4 mm | In distribution |
| 19028-35-50 | Outer Diameter 3.5 mm | In distribution |
| 19020-35-30 | Outer Diameter 3.5 mm | In distribution |
| 18620-50-55 | Outer Diameter 5 mm | In distribution |
| 18030-50-36 | Outer Diameter 5.0 mm | In distribution |
| 19003-45-50 | Outer Diameter 4.5 mm | In distribution |
| 18222-35-55-300 | In distribution | |
| 18210-40-120 | In distribution | |
| 18620-45-30 | Length 30 mm | In distribution |
| 19008-55-30 | Length 30 mm | In distribution |
| 18000-35-14 | Outer Diameter 3.5 mm | In distribution |
| 18301-50 | In distribution | |
| AIX400-60 | Outer Diameter 6.0 mm | In distribution |
| 18091-50-12 | Length 12 mm | In distribution |
| 18222-35-55-400 | In distribution | |
| 18000-55-34 | Length 34 mm | In distribution |
| 19000-55-60 | Length 60 mm | In distribution |
| 19018-40-24 | Outer Diameter 4 mm | In distribution |
| 19010-35-18 | Outer Diameter 3.5 mm | In distribution |
| 19009-45-50 | Length 50 mm | In distribution |
| 19018-35-48 | Outer Diameter 3.5 mm | In distribution |
| 19008-45-32 | Outer Diameter 4.5 mm | In distribution |
| 19003-45-34 | Outer Diameter 4.5 mm | In distribution |
| 18220-35-60-300 | In distribution | |
| 19010-55-36 | Outer Diameter 5.5 mm | In distribution |
| 18000-50-30 | Length 30 mm | In distribution |
| 19010-40-10 | Outer Diameter 4 mm | In distribution |
| 19020-50-26 | Length 26 mm | In distribution |
| 19010-55-40 | Outer Diameter 5.5 mm | In distribution |
| 19008-55-35 | Length 35 mm | In distribution |
| 18610-55-30 | Length 30 mm | In distribution |
| 19008-35-48 | Outer Diameter 3.5 mm | In distribution |
| 19018-40-52 | Length 52 mm | In distribution |
| AIX402-60-1 | Outer Diameter 6.0 mm | In distribution |
| 19008-55-60 | Length 60 mm | In distribution |
| 19000-40-44 | Length 44 mm | In distribution |
| 19020-40-54 | Outer Diameter 4 mm | In distribution |
| 19028-45-24 | Length 24 mm | In distribution |
| 19020-55-24 | Outer Diameter 5.5 mm | In distribution |
| 18000-50-36 | Length 36 mm | In distribution |
| 19010-50-20 | Outer Diameter 5 mm | In distribution |
| 18610-45-14 | Outer Diameter 4.5 mm | In distribution |
| 18210-35-110 | In distribution | |
| 18610-45-50 | Length 50 mm | In distribution |
| 18000-35-16 | Outer Diameter 3.5 mm | In distribution |
| 19000-50-35 | Outer Diameter 5 mm | In distribution |
| 19009-40-54 | Length 54 mm | In distribution |
| 18701-25 | In distribution | |
| 18000-40-20 | Outer Diameter 4 mm | In distribution |
| 19028-50-15 | Outer Diameter 5 mm | In distribution |
| 18030-55-24 | Length 24 mm | In distribution |
| 19018-40-26 | Outer Diameter 4 mm | In distribution |
| 19010-50-26 | Outer Diameter 5 mm | In distribution |
| 18610-50-32 | Length 32 mm | In distribution |
| 18030-40-56 | Outer Diameter 4.0 mm | In distribution |
| 18610-45-18 | Length 18 mm | In distribution |
| 18020-45-30 | In distribution | |
| 19003-45-24 | Outer Diameter 4.5 mm | In distribution |
| 19010-45-40 | Outer Diameter 4.5 mm | In distribution |
| 19008-55-36 | Length 36 mm | In distribution |
| 19018-35-42 | Outer Diameter 3.5 mm | In distribution |
| 18000-55-40 | Outer Diameter 5.5 mm | In distribution |
| 18610-55-34 | Length 34 mm | In distribution |
| 19009-45-52 | Outer Diameter 4.5 mm | In distribution |
| 18610-40-40 | Length 40 mm | In distribution |
| 19018-55-10 | Outer Diameter 5.5 mm | In distribution |
| 18620-40-20 | Length 20 mm | In distribution |
| 19003-45-36 | Outer Diameter 4.5 mm | In distribution |
| 19020-40-44 | Length 44 mm | In distribution |
| 19020-55-22 | Length 22 mm | In distribution |
| 19003-40-36 | Length 36 mm | In distribution |
| 19018-35-24 | Length 24 mm | In distribution |
| 19000-40-60 | Length 60 mm | In distribution |
| 19028-35-56 | Outer Diameter 3.5 mm | In distribution |
| 18030-35-32 | Outer Diameter 3.5 mm | In distribution |
| 19008-45-60 | Outer Diameter 4.5 mm | In distribution |
| 18702-35-45 | Length 45 mm | In distribution |
| 19018-40-40 | Length 40 mm | In distribution |
| 18620-35-12 | Length 12 mm | In distribution |
| 19010-40-18 | Outer Diameter 4 mm | In distribution |
| 18000-45-36 | Outer Diameter 4.5 mm | In distribution |
| 19000-55-24 | Length 24 mm | In distribution |
| 18301-40 | In distribution | |
| 19010-40-32 | Length 32 mm | In distribution |
| 19020-35-22 | Length 22 mm | In distribution |
| 19018-40-28 | Outer Diameter 4 mm | In distribution |
| 18200-40-240 | Length 240 mm | In distribution |
| 18701-40 | In distribution | |
| 19008-55-32 | Length 32 mm | In distribution |
| 19010-35-56 | Outer Diameter 3.5 mm | In distribution |
| 19010-55-35 | Outer Diameter 5.5 mm | In distribution |
| 18200-40-300 | Length 300 mm | In distribution |
| 18610-55-28 | Outer Diameter 5.5 mm | In distribution |
| 19008-50-22 | Length 22 mm | In distribution |
| 19028-40-44 | Length 44 mm | In distribution |
| 19000-45-35 | Length 35 mm | In distribution |
| 18030-55-38 | Length 38 mm | In distribution |
| 19028-35-40 | Length 40 mm | In distribution |
| 19028-40-28 | Length 28 mm | In distribution |
| 19018-40-48 | Length 48 mm | In distribution |
| 19018-40-34 | Outer Diameter 4 mm | In distribution |
| 18000-55-24 | Outer Diameter 5.5 mm | In distribution |
| 18610-35-32 | Outer Diameter 3.5 mm | In distribution |
| 19020-35-60 | Outer Diameter 3.5 mm | In distribution |
| 18030-45-22 | Outer Diameter 4.5 mm | In distribution |
| 18610-40-10 | Outer Diameter 4 mm | In distribution |
| 18610-55-45 | Outer Diameter 5.5 mm | In distribution |
| 18402-35-35 | In distribution | |
| 18702-35-35 | Outer Diameter 3.5 mm | In distribution |
| 18030-50-45 | Length 45 mm | In distribution |
| 19020-35-12 | Outer Diameter 3.5 mm | In distribution |
| 18620-50-14 | Length 14 mm | In distribution |
| 19028-45-16 | Length 16 mm | In distribution |
| 19003-40-38 | Outer Diameter 4 mm | In distribution |
| 18000-45-26 | Outer Diameter 4.5 mm | In distribution |
| 18003-40-34 | Outer Diameter 4 mm | In distribution |
| 19028-55-60 | Outer Diameter 5.5 mm | In distribution |
| 19028-35-14 | Length 14 mm | In distribution |
| 19009-45-28 | Outer Diameter 4.5 mm | In distribution |
| 19018-45-50 | Length 50 mm | In distribution |
| 19010-40-14 | Length 14 mm | In distribution |
| 18610-40-50 | Outer Diameter 4 mm | In distribution |
| 18610-55-18 | Outer Diameter 5.5 mm | In distribution |
| 18003-40-28 | Outer Diameter 4 mm | In distribution |
| 19000-45-50 | Outer Diameter 4.5 mm | In distribution |
| 19010-40-36 | Outer Diameter 4 mm | In distribution |
| 18610-40-48 | Outer Diameter 4 mm | In distribution |
| 18610-55-50 | Length 50 mm | In distribution |
| 19028-55-12 | Length 12 mm | In distribution |
| 19018-40-58 | Outer Diameter 4 mm | In distribution |
| 18000-45-20 | Length 20 mm | In distribution |
| 19000-45-16 | Length 16 mm | In distribution |
| 19003-40-24 | Length 24 mm | In distribution |
| 18620-45-55 | Outer Diameter 4.5 mm | In distribution |
| 19018-35-60 | Outer Diameter 3.5 mm | In distribution |
| 19000-55-38 | Outer Diameter 5.5 mm | In distribution |
| 18620-55-30 | Length 30 mm | In distribution |
| 19009-40-44 | Outer Diameter 4 mm | In distribution |
| 19301-50 | In distribution | |
| 18210-35-055 | Length 55 mm | In distribution |
| 19009-35-28 | Length 28 mm | In distribution |
| 19008-35-16 | Length 16 mm | In distribution |
| 19020-50-38 | Outer Diameter 5 mm | In distribution |
| 18010-40-26 | Outer Diameter 4 mm | In distribution |
| 19010-40-22 | Length 22 mm | In distribution |
| 18000-35-28 | Length 28 mm | In distribution |
| 19008-50-50 | Length 50 mm | In distribution |
| 18610-45-32 | Outer Diameter 4.5 mm | In distribution |
| 19010-55-60 | Outer Diameter 5.5 mm | In distribution |
| 19028-40-32 | Outer Diameter 4 mm | In distribution |
| 19003-35-28 | Outer Diameter 3.5 mm | In distribution |
| 18030-50-26 | Length 26 mm | In distribution |
| 18701-35 | In distribution | |
| 19000-35-24 | Outer Diameter 3.5 mm | In distribution |
| 19009-35-32 | Outer Diameter 3.5 mm | In distribution |
| 19018-55-60 | Length 60 mm | In distribution |
| 19010-40-20 | Outer Diameter 4 mm | In distribution |
| 18620-45-34 | Outer Diameter 4.5 mm | In distribution |
| 18210-40-025 | Length 25 mm | In distribution |
| 18210-35-040 | Outer Diameter 3.5 mm | In distribution |
| 19020-40-60 | Outer Diameter 4 mm | In distribution |
| 19003-40-32 | Outer Diameter 4 mm | In distribution |
| 18210-40-055 | Outer Diameter 4 mm | In distribution |
| 18210-40-030 | Outer Diameter 4 mm | In distribution |
| 19020-55-35 | Length 35 mm | In distribution |
| 18240-35 | Outer Diameter 3.5 mm | In distribution |
| 19028-55-30 | Length 30 mm | In distribution |
| 19020-40-40 | Outer Diameter 4 mm | In distribution |
| 19018-40-56 | Outer Diameter 4 mm | In distribution |
| 18610-50-55 | Outer Diameter 5 mm | In distribution |
| 18400-35-55 | In distribution | |
| 19000-55-40 | Outer Diameter 5.5 mm | In distribution |
| 19010-35-46 | Outer Diameter 3.5 mm | In distribution |
| 19010-35-30 | Length 30 mm | In distribution |
| 18220-35-55-400 | In distribution | |
| 18500-66 | Length 66 mm | In distribution |
| 18610-50-60 | Outer Diameter 5 mm | In distribution |
| 19010-55-12 | Length 12 mm | In distribution |
| 19020-45-35 | Length 35 mm | In distribution |
| 19000-40-56 | Outer Diameter 4 mm | In distribution |
| 18020-45-28 | In distribution | |
| 19008-35-44 | Outer Diameter 3.5 mm | In distribution |
| 18030-35-46 | Outer Diameter 3.5 mm | In distribution |
| 19010-50-22 | Outer Diameter 5 mm | In distribution |
| 19010-40-34 | Outer Diameter 4 mm | In distribution |
| 19008-35-56 | Length 56 mm | In distribution |
| 18610-35-50 | Outer Diameter 3.5 mm | In distribution |
| 19020-35-40 | Outer Diameter 3.5 mm | In distribution |
| 18620-45-10 | Length 10 mm | In distribution |
| 18610-35-14 | Outer Diameter 3.5 mm | In distribution |
| 18030-50-55 | Length 55 mm | In distribution |
| 19020-50-22 | Length 22 mm | In distribution |
| 18010-35-28 | Outer Diameter 3.5 mm | In distribution |
| 19003-40-18 | Outer Diameter 4 mm | In distribution |
| 19009-40-40 | Length 40 mm | In distribution |
| 18610-50-10 | Length 10 mm | 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 |
| 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 |
| Perla ® | Spineart SA | 349 |
Showing 12 of 336. All products under Posterior Cervical Screw System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203125 | 2020-12-18 |
| K200936 | 2020-05-22 |
| K191185 | 2019-06-03 |
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.