Gibralt
GIBRALT,SCREW,POLYAXIAL,5.5X30
13manufacturers in China registered for this device type
63catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 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 |
| 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 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Changzhou Yonghua Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spinal Pedicle Fixation
Record
| Listed by | Choice Spine, LP |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| 510(k) | K110197 |
| Record published | 2016-03-24 |
| Record revised | 2025-07-02 (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, expiry date, serial number |
| Sizes | Outer diameter 3.5 to 6 mm; length 10 to 90 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 05-000-26-3534 | Length 34 mm | In distribution |
| 05-000-20-4018 | Outer Diameter 4.0 mm | In distribution |
| 05-000-20-3530 | Outer Diameter 3.5 mm | In distribution |
| 05-000-20-4550 | Outer Diameter 4.5 mm | In distribution |
| 05-000-20-3522 | Outer Diameter 3.5 mm | In distribution |
| 05-004-00-2834 | 28mm – 34mm length | In distribution |
| 05-004-07-3555 | Outer Diameter 3.5 mm | In distribution |
| 05-002-03-3570 | Length 70 mm | In distribution |
| 05-000-26-3524 | Length 24 mm | In distribution |
| 05-004-06-3560 | Outer Diameter 6.0 mm | In distribution |
| 05-000-26-3546 | Length 46 mm | In distribution |
| 05-000-20-5530 | Length 30 mm | In distribution |
| 05-000-26-3532 | Length 32 mm | In distribution |
| 05-000-20-3538 | Outer Diameter 3.5 mm | In distribution |
| 05-002-03-3580 | curved | In distribution |
| 05-000-20-5545 | Length 45 mm | In distribution |
| 05-002-03-3590 | Length 90 mm | In distribution |
| 05-000-20-4010 | Outer Diameter 4.0 mm | In distribution |
| 05-000-20-5540 | Outer Diameter 5.5 mm | In distribution |
| 05-000-20-4030 | Outer Diameter 4.0 mm | In distribution |
| 05-006-01-3504 | Outer Diameter 3.5 mm | In distribution |
| 05-000-20-4530 | Outer Diameter 4.5 mm | In distribution |
| 05-004-08-3512 | Outer Diameter 3.5 mm | In distribution |
| 05-000-24-0003 | In distribution | |
| 05-000-24-1000 | In distribution | |
| 05-000-26-3528 | Length 28 mm | In distribution |
| 05-000-20-3518 | Outer Diameter 3.5 mm | In distribution |
| 05-000-24-0925 | In distribution | |
| 05-006-01-3501 | Outer Diameter 3.5 mm | In distribution |
| 05-004-00-4046 | 40mm – 46mm length | In distribution |
| 05-002-03-3540 | Outer Diameter 3.5 mm | In distribution |
| 05-000-26-3526 | Length 26 mm | In distribution |
| 05-002-03-3560 | Outer Diameter 3.5 mm | In distribution |
| 05-000-20-3514 | Outer Diameter 3.5 mm | In distribution |
| 05-004-00-2228 | 22mm – 28mm length | In distribution |
| 05-000-20-3534 | Outer Diameter 3.5 mm | In distribution |
| 05-004-07-3560 | Outer Diameter 6.0 mm | In distribution |
| 05-004-05-3535 | Outer Diameter 3.5 mm | In distribution |
| 05-002-03-3550 | Outer Diameter 3.5 mm | In distribution |
| 05-006-01-3503 | Outer Diameter 3.5 mm | In distribution |
| 05-000-20-5520 | Length 20 mm | In distribution |
| 05-002-00-3536 | Length 36 mm | In distribution |
| 05-000-20-4520 | Outer Diameter 4.5 mm | In distribution |
| 05-002-00-3512 | Length 12 mm | In distribution |
| 05-006-01-3505 | Outer Diameter 3.5 mm | In distribution |
| 05-006-01-3502 | Outer Diameter 3.5 mm | In distribution |
| 05-004-00-4652 | 46mm – 52mm length | In distribution |
| 05-002-03-3530 | Outer Diameter 3.5 mm | In distribution |
| 05-000-20-4014 | Outer Diameter 4.0 mm | In distribution |
| 05-000-20-5535 | Length 35 mm | In distribution |
| 05-000-26-3520 | Outer Diameter 3.5 mm | In distribution |
| 05-000-20-4026 | Outer Diameter 4.0 mm | In distribution |
| 05-000-20-4022 | Outer Diameter 4.0 mm | In distribution |
| 05-000-20-4540 | Outer Diameter 4.5 mm | In distribution |
| 05-000-20-5525 | Outer Diameter 5.5 mm | In distribution |
| 05-000-20-3526 | Outer Diameter 3.5 mm | In distribution |
| 05-004-00-3440 | 34mm – 40mm length | In distribution |
| 05-000-26-3522 | Length 22 mm | In distribution |
| 05-004-06-3555 | Outer Diameter 3.5 mm | In distribution |
| 05-000-20-4034 | Outer Diameter 4.0 mm | In distribution |
| 05-004-08-3515 | Length 15 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 |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 2,342 |
| Creo | Globus Medical, Inc. | 1,784 |
| ReLine | Nuvasive, Inc. | 1,718 |
| AnyPlus Spinal Fixation System | GS Medical Co., Ltd. | 1,525 |
| Apex Spine System | Spinecraft LLC | 1,114 |
| Revere | Globus Medical, Inc. | 1,051 |
| LnK Spinal Fixation System | L&K Biomed Co., Ltd. | 974 |
| LnK Basic Spinal Fixation System | L&K Biomed Co., Ltd. | 935 |
| Arsenal | Alphatec Spine, Inc. | 932 |
| Zavation | Zavation | 864 |
| Polaris™ 5.5 Spinal System | Biomet Spine | 809 |
| Apex-DL Spine System | Spinecraft LLC | 792 |
Showing 12 of 950. All products under Orthosis, Spinal Pedicle Fixation
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.