Gibralt®
POSTERIOR CERVICAL, SELF ALIGNING DRIVER WITH FIXED HANDLE, SST, Medcoat 2000, Radel
4manufacturers in China registered for this device type
133catalogue 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 | Inno-Health Technology Co., Ltd., Taiwan |
|---|---|
| FDA product code | NKG |
| Device type | Posterior Cervical Screw System |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3075 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer |
| 510(k) | K192354 |
| Record published | 2024-02-29 |
| Record revised | 2025-12-31 (version 6) |
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, serial number |
| Sizes | Length 10 to 600 mm; outer diameter 2.4 to 4.5 mm; lumen/inner diameter 3.5 mm |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 05-000-26-3524 | Length 24 mm | In distribution |
| 05-006-01-3505 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 05-002-10-3512 | Length 120 mm | In distribution |
| 05-000-20-3536 | Outer Diameter 3.5 mm | In distribution |
| 05-002-03-3560 | Length 60 mm | In distribution |
| 05-000-26-3520 | Length 20 mm | In distribution |
| 05-006-01-3504 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 05-000-20-3528 | Length 28 mm | In distribution |
| 05-000-26-4038 | Length 38 mm | In distribution |
| 05-000-26-3534 | Length 34 mm | In distribution |
| 05-000-20-3526 | Outer Diameter 3.5 mm | In distribution |
| 05-002-01-0001 | Length 420 mm | In distribution |
| PC-185 | In distribution | |
| 05-002-01-0004 | Length 600 mm | In distribution |
| 05-000-20-4028 | Outer Diameter 4.0 mm | In distribution |
| 05-000-26-3540 | Length 40 mm | In distribution |
| PC-166 | In distribution | |
| 05-000-20-4026 | Outer Diameter 4.0 mm | In distribution |
| 05-000-26-3530 | Length 30 mm | In distribution |
| PC-140 | In distribution | |
| 05-000-20-3522 | Outer Diameter 3.5 mm | In distribution |
| 05-006-01-3502 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 05-002-00-3536 | Length 360 mm | In distribution |
| 05-000-20-4020 | Outer Diameter 4.0 mm | In distribution |
| 05-000-20-4012 | Outer Diameter 4.0 mm | In distribution |
| 05-000-26-4044 | Length 44 mm | In distribution |
| 05-000-20-3516 | Length 16 mm | In distribution |
| 05-000-20-4022 | Outer Diameter 4.0 mm | In distribution |
| 05-004-00-3848 | 38-48mm | In distribution |
| 05-004-08-3512 | Length 12 mm | In distribution |
| 05-004-00-2230 | 22-30mm | In distribution |
| 05-000-20-3524 | Outer Diameter 3.5 mm | In distribution |
| 05-004-10-2230 | 22-30 Millimeter | In distribution |
| 05-000-26-4032 | Length 32 mm | In distribution |
| 05-000-26-4036 | Length 36 mm | In distribution |
| 05-002-13-3590 | Length 90 mm | In distribution |
| 05-002-03-3590 | Length 90 mm | In distribution |
| 05-000-20-4036 | Outer Diameter 4.0 mm | In distribution |
| PC-193 | In distribution | |
| PC-156 | In distribution | |
| 05-000-20-4014 | Outer Diameter 4.0 mm | In distribution |
| PC-188 | In distribution | |
| 05-004-10-4452 | 44-52 Millimeter | In distribution |
| 05-000-20-3540 | Outer Diameter 3.5 mm | In distribution |
| 05-000-20-4016 | Outer Diameter 4.0 mm | In distribution |
| PC-141 | In distribution | |
| 05-004-10-3242 | 32-42 Millimeter | In distribution |
| 05-000-20-4540 | Outer Diameter 4.5 mm | In distribution |
| PC-119 | In distribution | |
| 05-000-26-4046 | Length 46 mm | In distribution |
| 05-000-20-4545 | Outer Diameter 4.5 mm | In distribution |
| 05-000-20-3520 | Outer Diameter 3.5 mm | In distribution |
| 05-002-10-3524 | Length 240 mm | In distribution |
| 05-002-10-3536 | Length 360 mm | In distribution |
| 05-002-01-0002 | Length 420 mm | In distribution |
| 05-002-03-3570 | Length 70 mm | In distribution |
| 05-000-20-3512 | Outer Diameter 3.5 mm | In distribution |
| 05-004-00-2636 | 26-36mm | In distribution |
| 05-000-26-4034 | Length 34 mm | In distribution |
| 05-000-20-4530 | Outer Diameter 4.5 mm | In distribution |
| 05-002-03-3530 | Length 30 mm | In distribution |
| 05-004-08-3515 | Length 15 mm | In distribution |
| 05-000-26-3544 | Length 44 mm | In distribution |
| 05-000-20-3530 | Outer Diameter 3.5 mm | In distribution |
| 05-000-26-4024 | Length 24 mm | In distribution |
| 05-002-10-3508 | Length 80 mm | In distribution |
| 05-000-20-4034 | Outer Diameter 4.0 mm | In distribution |
| 05-000-26-3536 | Length 36 mm | In distribution |
| 05-000-26-3526 | Length 26 mm | In distribution |
| 05-000-20-3510 | Outer Diameter 3.5 mm | In distribution |
| 05-000-20-4038 | Outer Diameter 4.0 mm | In distribution |
| 05-000-26-4026 | Length 26 mm | In distribution |
| 05-000-26-3546 | Length 46 mm | In distribution |
| 05-002-00-3524 | Length 240 mm | In distribution |
| 05-002-13-3540 | Length 40 mm | In distribution |
| PC-153 | In distribution | |
| 05-004-00-0000 | In distribution | |
| PC-187 | In distribution | |
| 05-000-26-3522 | Length 22 mm | In distribution |
| 05-000-20-3532 | Outer Diameter 3.5 mm | In distribution |
| 05-000-20-4520 | Outer Diameter 4.5 mm | In distribution |
| 05-000-26-4028 | Length 28 mm | In distribution |
| 05-002-01-0003 | Length 600 mm | In distribution |
| 05-002-03-3580 | Length 80 mm | In distribution |
| 05-000-20-4040 | Outer Diameter 4.0 mm | In distribution |
| 05-002-13-3530 | Length 30 mm | In distribution |
| 05-000-20-4550 | Outer Diameter 4.5 mm | In distribution |
| 05-004-00-3242 | 32-42mm | In distribution |
| 05-004-05-3535 | Diameter 3.5 | In distribution |
| PC-165 | In distribution | |
| 05-004-07-3560 | Diameter 3.5-6.0 | In distribution |
| 05-000-24-0002 | In distribution | |
| 05-004-10-2636 | 26-36 Millimeter | In distribution |
| 05-002-00-3512 | Length 120 mm | In distribution |
| 05-000-20-3514 | Outer Diameter 3.5 mm | In distribution |
| 05-004-06-3560 | Diameter 3.5-6.0 | In distribution |
| 05-006-01-3503 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 05-000-26-4030 | Length 30 mm | In distribution |
| 05-000-20-4024 | Outer Diameter 4.0 mm | In distribution |
| PC-133 | In distribution | |
| 05-000-26-4020 | Outer Diameter 4.0 mm | In distribution |
| 05-002-03-3550 | Length 50 mm | In distribution |
| 05-006-01-3501 | Lumen/Inner Diameter 3.5 mm | In distribution |
| 05-000-26-3542 | Length 42 mm | In distribution |
| 05-000-26-4042 | Length 42 mm | In distribution |
| 05-000-26-3532 | Length 32 mm | In distribution |
| 05-002-00-3508 | Length 80 mm | In distribution |
| 05-000-26-4022 | Outer Diameter 4.0 mm | In distribution |
| 05-002-13-3550 | Length 50 mm | In distribution |
| PC-111-2412 | Outer Diameter 2.4 mm | In distribution |
| 05-004-00-4452 | 44-52mm | In distribution |
| 05-000-25-0001 | In distribution | |
| 05-002-13-3580 | Length 80 mm | In distribution |
| 05-000-20-4525 | Outer Diameter 4.5 mm | In distribution |
| 05-000-26-4040 | Length 40 mm | In distribution |
| 05-000-20-3518 | Length 18 mm | In distribution |
| 05-004-10-3848 | 38-48 Millimeter | In distribution |
| 05-000-20-4010 | Outer Diameter 4.0 mm | In distribution |
| 05-004-06-3555 | Diameter 3.5-5.5 | In distribution |
| 05-002-03-3540 | Length 40 mm | In distribution |
| 05-000-26-3528 | Length 28 mm | In distribution |
| 05-004-07-3555 | Diameter 3.5-5.5mm | In distribution |
| 05-000-20-4032 | Outer Diameter 4.0 mm | In distribution |
| 05-002-13-3560 | Length 60 mm | In distribution |
| 05-000-20-3538 | Outer Diameter 3.5 mm | In distribution |
| PC-111-2414 | Length 14 mm | In distribution |
| 05-002-13-3570 | Length 70 mm | Withdrawn |
| 05-000-24-0003 | Withdrawn | |
| 05-000-26-3538 | Length 38 mm | Withdrawn |
| 05-000-20-4535 | Outer Diameter 4.5 mm | Withdrawn |
| 05-000-20-4018 | Outer Diameter 4.0 mm | Withdrawn |
| 05-000-24-0275 | Withdrawn | |
| 05-000-20-4030 | Outer Diameter 4.0 mm | Withdrawn |
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
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.