Gibralt
GIBRALT,CONNECTOR,SCREW-TO-SCREW,32-42
11manufacturers in China registered for this device type
86catalogue numbers in this listing
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 | Choice Spine, LP |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| 510(k) | K160697 |
| Record published | 2016-03-24 |
| Record revised | 2025-03-13 (version 5) |
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, expiry date, serial number |
| Sizes | Length 6 to 600 mm; outer diameter 3.5 to 5.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 05-002-00-3524 | Length 24 mm | In distribution |
| 05-002-01-0001 | Length 420 mm | In distribution |
| 05-000-24-0275 | In distribution | |
| 05-000-07-5014 | Outer Diameter 5 mm | In distribution |
| 05-002-13-3550 | Outer Diameter 3.5 mm | In distribution |
| 05-000-20-4020 | Length 20 mm | In distribution |
| 05-000-20-4040 | Length 40 mm | In distribution |
| 05-000-07-4514 | Outer Diameter 4.5 mm | In distribution |
| 05-004-09-3242 | In distribution | |
| 05-000-26-4030 | Length 30 mm | In distribution |
| 05-000-24-0002 | In distribution | |
| 05-008-01-0000 | 35-45mm width | In distribution |
| 05-000-20-4024 | Length 24 mm | In distribution |
| 05-000-20-4545 | Length 45 mm | In distribution |
| 05-000-20-4036 | Length 36 mm | In distribution |
| 05-000-07-5010 | Outer Diameter 5 mm | In distribution |
| 05-004-00-2636 | 26mm – 36mm length | In distribution |
| 05-000-26-3538 | Length 38 mm | In distribution |
| 05-004-00-3848 | 38mm – 48mm length | In distribution |
| 05-000-20-4535 | Length 35 mm | In distribution |
| 05-000-07-4516 | Length 16 mm | In distribution |
| 05-002-00-3508 | Length 8 mm | In distribution |
| 05-004-10-2636 | 26mm-36mm length | In distribution |
| 05-000-26-4042 | Length 42 mm | In distribution |
| 05-000-07-5012 | Length 12 mm | In distribution |
| 05-000-20-5550 | Outer Diameter 5.5 mm | In distribution |
| 05-000-26-3530 | Length 30 mm | In distribution |
| 05-000-20-3540 | Length 40 mm | In distribution |
| 05-000-20-3528 | Length 28 mm | In distribution |
| 05-000-20-4012 | Length 12 mm | In distribution |
| 05-004-11-2230 | In distribution | |
| 05-000-26-4026 | Length 26 mm | In distribution |
| 05-000-07-5016 | Length 16 mm | In distribution |
| 05-004-11-3848 | In distribution | |
| 05-004-09-2636 | In distribution | |
| 05-000-26-4046 | Length 46 mm | In distribution |
| 05-008-00-0000 | 25-35mm width | In distribution |
| 05-000-20-4016 | Length 16 mm | In distribution |
| 05-004-10-3848 | 38mm-48mm length | In distribution |
| 05-002-13-3570 | Outer Diameter 3.5 mm | In distribution |
| 05-000-20-3524 | Length 24 mm | In distribution |
| 05-000-07-5006 | Outer Diameter 5 mm | In distribution |
| 05-000-26-3536 | Length 36 mm | In distribution |
| 05-000-20-3516 | Length 16 mm | In distribution |
| 05-000-26-4032 | Length 32 mm | In distribution |
| 05-000-26-3542 | Length 42 mm | In distribution |
| 05-000-20-4028 | Length 28 mm | In distribution |
| 05-000-26-4040 | Length 40 mm | In distribution |
| 05-000-26-3540 | Length 40 mm | In distribution |
| 05-000-20-3512 | Length 12 mm | In distribution |
| 05-002-02-0000 | In distribution | |
| 05-000-25-0001 | In distribution | |
| 05-000-24-2000 | In distribution | |
| 05-002-13-3530 | Length 30 mm | In distribution |
| 05-000-26-3544 | Length 44 mm | In distribution |
| 05-002-01-0003 | Length 420 mm | In distribution |
| 05-000-26-4034 | Length 34 mm | In distribution |
| 05-004-00-4452 | 44mm – 52mm length | In distribution |
| 05-000-26-4044 | Length 44 mm | In distribution |
| 05-004-11-2636 | In distribution | |
| 05-000-20-4032 | Length 32 mm | In distribution |
| 05-004-09-4452 | In distribution | |
| 05-000-26-4022 | Length 22 mm | In distribution |
| 05-000-26-4036 | Length 36 mm | In distribution |
| 05-000-20-3520 | Length 20 mm | In distribution |
| 05-000-07-4510 | Outer Diameter 4.5 mm | In distribution |
| 05-004-00-2230 | 22mm – 30mm length | In distribution |
| 05-000-26-4028 | Length 28 mm | In distribution |
| 05-000-26-4020 | Length 20 mm | In distribution |
| 05-000-20-3536 | Length 36 mm | In distribution |
| 05-000-07-5008 | Length 8 mm | In distribution |
| 05-002-01-0004 | Length 600 mm | In distribution |
| 05-000-07-4508 | Length 8 mm | In distribution |
| 05-002-10-3508 | Length 80 mm | In distribution |
| 05-004-00-3242 | 32mm – 42mm length | In distribution |
| 05-002-13-3590 | Outer Diameter 3.5 mm | In distribution |
| 05-000-26-4038 | Length 38 mm | In distribution |
| 05-000-20-3532 | Length 32 mm | In distribution |
| 05-000-26-4024 | Length 24 mm | In distribution |
| 05-000-20-4525 | Length 25 mm | In distribution |
| 05-004-09-2230 | In distribution | |
| 05-004-11-4452 | In distribution | |
| 05-002-01-0002 | Length 420 mm | In distribution |
| 05-000-07-4512 | Length 12 mm | In distribution |
| 05-000-07-4506 | Outer Diameter 4.5 mm | In distribution |
| 05-002-10-3524 | Length 240 mm | In distribution |
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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Exactech, Inc. | 510(k) number | 2014-01-06 | Class II | Mixed-up of materials/components | The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium alloy. | 242 | 2014-08-04 |
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.