Malibu
ANGLED HOOK, 5.5 X 6.5mm, LEFT. The Malibu system contains polyaxial screws of varying reduction height, cannulated polyaxial screws of varying reduction height, uniplanar screws of varying…
ANGLED HOOK, 5.5 X 6.5mm, LEFT. The Malibu system contains polyaxial screws of varying reduction height, cannulated polyaxial screws of varying reduction height, uniplanar screws of varying reduction height, monoaxial screws, iliac onoaxial screws, rods, rod connectors, screw spacers, crossbars, sublaminar wires and hooks. Implants are offered in a variety of lengths to accommodate variations in patient anatomy and are manufactured from Titanium 6Aluminum-4Vanadium ELI, with the exception of the Malibu and NewPort Cobaltt
13manufacturers in China registered for this device type
231catalogue 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 | Seaspine Orthopedics Corporation, United States |
|---|---|
| FDA product code | MNI |
| Device type | Orthosis, Spinal Pedicle Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K122571 |
| Record published | 2015-09-24 |
| Record revised | 2025-10-24 (version 8) |
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 |
| Distribution end date | 2016-09-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 69-6530 | 6.5 X 30 | In distribution |
| 12-3052 | MEDIUM, 6.35mm ROD | In distribution |
| 18-5540 | Diameter 5.5 x 40mm | In distribution |
| 71-6545 | 6.5 DIA x 45mm | In distribution |
| 70-5545 | 5.5 x 45mm | In distribution |
| 12-0020 | 8 | In distribution |
| 13-8510 | 8.5 x 110mm | In distribution |
| 16-6540 | 6.5 x 40mm | In distribution |
| 17-5595 | 5.5mm X 9.5mm | In distribution |
| 75-7530 | Diameter 7.5 x 30mm | In distribution |
| 75-5550 | Diameter 5.5 x 50mm | In distribution |
| 15-4530 | 4.5 DIA X 30 mm | In distribution |
| 75-7535 | Diameter 7.5 x 35mm | In distribution |
| 13-7535 | 7.5 x 35mm | In distribution |
| 12-1075 | 5.5mm x 75mm | In distribution |
| 16-4535 | 4.5 x 35mm | In distribution |
| 12-0350 | 7.0-7.5mm DIA X 5.0mm | In distribution |
| 15-1400 | 5.5mm x 400mm | In distribution |
| 68-6555 | 6.5 DIA x 55mm | In distribution |
| 13-6540 | 6.5 x 40mm | In distribution |
| 75-6040 | Diameter 6.0 x 40mm | In distribution |
| 17-3511 | 5.5 x 11mm | In distribution |
| 91-2602 | In distribution | |
| 71-7545 | 7.5 DIA x 45mm | In distribution |
| 16-5525 | 5.5 x 25mm | In distribution |
| 12-7560 | 7.5 x 60mm | In distribution |
| 13-6535 | 6.5 x 35mm | In distribution |
| 12-1050 | 5.5mm x 50mm | In distribution |
| 75-5540 | Diameter 5.5 x 40mm | In distribution |
| 12-1300 | 5.5mm X 300mm | In distribution |
| 13-8500 | 8.5 x 100mm | In distribution |
| 13-6545 | 6.5 x 45mm | In distribution |
| 12-0225 | 6.0-6.5mm DIA X 2.5mm | In distribution |
| 13-5525 | 5.5 x 25mm | In distribution |
| 91-2981 | 4.8 x 60mm | In distribution |
| 17-7065 | 7.0mm X 6.5mm | In distribution |
| 67-6555 | 6.5 DIA x 55mm | In distribution |
| 18-7540 | Diameter 7.5 x 40mm | In distribution |
| 75-5560 | Diameter 5.5 x 60mm | In distribution |
| 17-7565 | 7.5mm X 6.5mm | In distribution |
| 76-0010 | In distribution | |
| 12-2052 | MEDIUM, 5.5mm ROD | In distribution |
| 75-6055 | Diameter 6.0 x 55mm | In distribution |
| 12-6570 | 6.5 x 70mm | In distribution |
| 16-3400 | In distribution | |
| 13-5545 | 5.5 x 45mm | In distribution |
| 15-2250 | In distribution | |
| 18-6545 | Diameter 6.5 x 45mm | In distribution |
| 18-5545 | Diameter 5.5 x 45mm | In distribution |
| 12-1070 | 5.5mm x 70mm | In distribution |
| 12-0051 | 5.5mm X 30MM | In distribution |
| 15-0100 | 5.5mm x 100mm | In distribution |
| 16-7555 | 7.5 x 55mm | In distribution |
| 12-7530 | 7.5 x 30mm | In distribution |
| 16-6530 | 6.5 x 30mm | In distribution |
| 70-5540 | 5.5 x 40mm | In distribution |
| 15-1500 | 5.5mm x 500mm | In distribution |
| 74-6575 | 6.5 DIA x 75mm | In distribution |
| 69-7550 | 7.5 X 50 | In distribution |
| 16-4400 | In distribution | |
| 17-5580 | 5.5mm X 8.0mm | In distribution |
| 75-7040 | Diameter 7.0 x 40mm | In distribution |
| 69-5530 | 5.5 X 30 | In distribution |
| 13-5540 | 5.5 x 40mm | In distribution |
| 74-7050 | 7.0 DIA x 50mm | In distribution |
| 13-5530 | 5.5 x 30mm | In distribution |
| 12-6560 | 6.5 x 60mm | In distribution |
| 74-7025 | 7.0 DIA x 25mm | In distribution |
| 75-6540 | Diameter 6.5 x 40mm | In distribution |
| 71-6540 | 6.5 DIA x 40mm | In distribution |
| 16-7540 | 7.5 x 40mm | In distribution |
| 16-0660 | 6.5mm x 60mm | In distribution |
| 12-4525 | 4.5 x 25mm | In distribution |
| 12-0145 | 4.5-8.5mm X 5.0mm | In distribution |
| 15-7550 | 7.5 DIA X 50 mm | In distribution |
| 12-5535 | 5.5 x 35mm | In distribution |
| 75-5525 | Diameter 5.5 x 25mm | In distribution |
| 17-1510 | 5.5 x10mm | In distribution |
| 17-0565 | 5.5 X 6.5mm, LEFT | In distribution |
| 12-0061 | 6.35mm X 30mm | In distribution |
| 69-6545 | 6.5 X 45 | In distribution |
| 73-7045 | 7.0 DIA x 45mm | Withdrawn |
| 12-6035 | 6.0 x 35mm | Withdrawn |
| 71-5555 | 5.5 DIA x 55mm | Withdrawn |
| 67-6585 | 6.5 DIA x 85mm | Withdrawn |
| 71-5025 | 5.0 DIA x 25mm | Withdrawn |
| 67-7050 | 7.0 DIA x 50mm | Withdrawn |
| 74-6050 | 6.0 DIA x 50mm | Withdrawn |
| 72-4550 | 4.5 DIA x 50mm | Withdrawn |
| 18-8565 | 8.5 x 65MM | Withdrawn |
| 70-6050 | 6.0 x 50mm | Withdrawn |
| 18-7070 | Diameter 7.0 x 70mm | Withdrawn |
| 67-5050 | 5.0 DIA x 50mm | Withdrawn |
| 18-7060 | Diameter 7.0 x 60mm | Withdrawn |
| 18-5530 | Diameter 5.5 x 30mm | Withdrawn |
| 12-8070 | 8.0 x 70mm | Withdrawn |
| 73-5540 | 5.5 DIA x 40mm | Withdrawn |
| 75-6025 | Diameter 6.0 x 25mm | Withdrawn |
| 74-7540 | 7.5 DIA x 40mm | Withdrawn |
| 67-5525 | 5.5 DIA x 25mm | Withdrawn |
| 74-7525 | 7.5 DIA x 25mm | Withdrawn |
| 13-6570 | 6.5 x 70mm | Withdrawn |
| 74-6580 | 6.5 DIA x 80mm | Withdrawn |
| 72-5555 | 5.5 DIA x 55mm | Withdrawn |
| 18-7555 | Diameter 7.5 x 55mm | Withdrawn |
| 13-8585 | 8.5 x 85mm | Withdrawn |
| 68-4545 | 4.5 DIA x 45mm | Withdrawn |
| 74-5555 | 5.5 DIA x 55mm | Withdrawn |
| 68-7025 | 7.0 DIA x 25mm | Withdrawn |
| 16-7565 | 7.5 x 65mm | Withdrawn |
| 74-6505 | 6.0 DIA x 105mm | Withdrawn |
| 18-6555 | Diameter 6.5 x 55mm | Withdrawn |
| 73-7525 | 7.5 DIA x 25mm | Withdrawn |
| 68-6505 | 6.5 DIA x 105mm | Withdrawn |
| 73-6535 | 6.5 DIA x 35mm | Withdrawn |
| 18-6050 | Diameter 6.0 x 50mm | Withdrawn |
| 12-7025 | 7.0 x 25mm | Withdrawn |
| 67-7070 | 7.0 DIA x 70mm | Withdrawn |
| 72-5530 | 5.5 DIA x 30mm | Withdrawn |
| 69-7045 | 7.0 X 45 | Withdrawn |
| 73-6570 | 6.5 DIA x 70mm | Withdrawn |
| 72-6565 | 6.5 DIA x 65mm | Withdrawn |
| 70-6055 | 6.0 x 55mm | Withdrawn |
| 71-7065 | 7.0 DIA x 65mm | Withdrawn |
| 69-6570 | 6.5 X 70 | Withdrawn |
| 69-7580 | 7.5 X 80 | Withdrawn |
| 71-6055 | 6.0 DIA x 55mm | Withdrawn |
| 70-5525 | 5.5 x 25mm | Withdrawn |
| 13-7060 | 7.0 x 60mm | Withdrawn |
| 18-7560 | Diameter 7.5 x 60mm | Withdrawn |
| 18-7565 | Diameter 7.5 x 65mm | Withdrawn |
| 72-7540 | 7.5 DIA x 40mm | Withdrawn |
| 72-7040 | 7.0 DIA x 40mm | Withdrawn |
| 70-4520 | 4.5 x 20mm | Withdrawn |
| 69-7575 | 7.5 X 75 | Withdrawn |
| 12-8090 | 8.0 x 90mm | Withdrawn |
| 72-6590 | 6.5 DIA x 90mm | Withdrawn |
| 18-8080 | 8.0 x 80MM | Withdrawn |
| 13-8075 | 8.0 x 75mm | Withdrawn |
| 16-8565 | 8.5 x 65mm | Withdrawn |
| 70-6530 | 6.5 x 30mm | Withdrawn |
| 72-5045 | 5.0 DIA x 45mm | Withdrawn |
| 13-8535 | 8.5 x 35m | Withdrawn |
| 12-8050 | 8.0 x 50mm | Withdrawn |
| 67-4530 | 4.5 DIA x 30mm | Withdrawn |
| 72-5535 | 5.5 DIA x 35mm | Withdrawn |
| 67-6030 | 6.0 DIA x 30mm | Withdrawn |
| 75-5555 | 5.5 x 55mm | Withdrawn |
| 15-6030 | 6.0 DIA X 30 mm | Withdrawn |
| 67-5045 | 5.0 DIA x 45mm | Withdrawn |
| 12-4555 | 4.5 x 55mm | Withdrawn |
| 70-7550 | 7.5 x 50mm | Withdrawn |
| 72-6030 | 6.0 DIA x 30mm | Withdrawn |
| 12-5060 | 5.0 x 60mm | Withdrawn |
| 12-7040 | 7.0 x 40mm | Withdrawn |
| 67-5545 | 5.5 DIA x 45mm | Withdrawn |
| 18-7065 | Diameter 7.0 x 65mm | Withdrawn |
| 15-7030 | 7.0 DIA X 30 mm | Withdrawn |
| 72-5525 | 5.5 DIA x 25mm | Withdrawn |
| 67-7025 | 7.0 DIA x 25mm | Withdrawn |
| 13-7585 | 7.5 x 85mm | Withdrawn |
| 72-4560 | 4.5 DIA x 60mm | Withdrawn |
| 71-7550 | 7.5 DIA x 50mm | Withdrawn |
| 69-6045 | 6.0 X 45 | Withdrawn |
| 74-6590 | 6.5 DIA x 90mm | Withdrawn |
| 71-6525 | 6.5 DIA x 25mm | Withdrawn |
| 18-7055 | Diameter 7.0 x 55mm | Withdrawn |
| 75-7525 | Diameter 7.5 x 25mm | Withdrawn |
| 13-6055 | 6.0 x 55mm | Withdrawn |
| 69-6565 | 6.5 X 65 | Withdrawn |
| 12-6595 | 6.5 x 95mm | Withdrawn |
| 12-7595 | 7.5 x 95mm | Withdrawn |
| 12-6575 | 6.5 x 75mm | Withdrawn |
| 68-5540 | 5.5 DIA x 40mm | Withdrawn |
| 67-5030 | 5.0 DIA x 30mm | Withdrawn |
| 12-7510 | 7.5 x 110mm | Withdrawn |
| 13-7045 | 7.0 x 45mm | Withdrawn |
| 70-6595 | 6.5 x 95mm | Withdrawn |
| 70-6525 | 6.5 x 25mm | Withdrawn |
| 70-6570 | 6.5 x 70mm | Withdrawn |
| 18-8045 | 8.0 x 45MM | Withdrawn |
| 16-8530 | 8.5 x 30mm | Withdrawn |
| 69-7560 | 7.5 X 60 | Withdrawn |
| 73-6045 | 6.0 DIA x 45mm | Withdrawn |
| 13-8060 | 8.0 x 60mm | Withdrawn |
| 67-6570 | 6.5 DIA x 70mm | Withdrawn |
| 16-8570 | 8.5 x 70mm | Withdrawn |
| 69-6060 | 6.0 X 60 | Withdrawn |
| 68-7530 | 7.5 DIA x 30mm | Withdrawn |
| 69-5045 | 5.0 X 45 | Withdrawn |
| 73-7055 | 7.0 DIA x 55mm | Withdrawn |
| 70-6585 | 6.5 x 85mm | Withdrawn |
| 75-6595 | Diameter 6.5 x 95mm | Withdrawn |
| 75-7025 | Diameter 7.0 x 25mm | Withdrawn |
| 68-5030 | 5.0 DIA x 30mm | Withdrawn |
| 18-6570 | Diameter 6.5 x 70mm | Withdrawn |
| 71-6035 | 6.0 DIA x 35mm | Withdrawn |
| 68-5545 | 5.5 DIA x 45mm | Withdrawn |
| 69-7070 | 7.0 X 70 | Withdrawn |
| 73-6525 | 6.5 DIA x 25mm | Withdrawn |
| 69-7525 | 7.5 X 25 | Withdrawn |
| 12-6060 | 6.0 x 60mm | Withdrawn |
| 70-4555 | 4.5 x 55mm | Withdrawn |
| 71-5050 | 5.0 DIA x 50mm | Withdrawn |
| 73-6500 | 6.0 DIA x 100mm | Withdrawn |
| 16-7560 | 7.5 x 60mm | Withdrawn |
| 74-6545 | 6.5 DIA x 45mm | Withdrawn |
| 70-5035 | 5.0 x 35mm | Withdrawn |
| 72-5040 | 5.0 DIA x 40mm | Withdrawn |
| 73-6550 | 6.5 DIA x 50mm | Withdrawn |
| 72-7530 | 7.5 DIA x 30mm | Withdrawn |
| 72-7555 | 7.5 DIA x 55mm | Withdrawn |
| 68-6030 | 6.0 DIA x 30mm | Withdrawn |
| 15-7575 | 7.5 DIA X 75 mm | Withdrawn |
| 18-8550 | 8.5 x 50MM | Withdrawn |
| 74-7055 | 7.0 DIA x 55mm | Withdrawn |
| 75-7070 | Diameter 7.0 x 70mm | Withdrawn |
| 71-5060 | 5.0 DIA x 60mm | Withdrawn |
| 12-8065 | 8.0 x 65mm | Withdrawn |
| 70-5060 | 5.0 x 60mm | Withdrawn |
| 70-4560 | 4.5 x 60mm | Withdrawn |
| 72-5540 | 5.5 DIA x 40mm | Withdrawn |
| 72-4530 | 4.5 DIA x 30mm | Withdrawn |
| 69-5560 | 5.5 X 60 | Withdrawn |
| 74-6550 | 6.5 DIA x 50mm | Withdrawn |
| 73-6030 | 6.0 DIA x 30mm | Withdrawn |
| 67-7030 | 7.0 DIA x 30mm | Withdrawn |
| 67-7060 | 7.0 DIA x 60mm | Withdrawn |
| 69-5555 | 5.5 X 55 | Withdrawn |
| 67-4545 | 4.5 DIA x 45mm | Withdrawn |
| 73-7570 | 7.5 DIA x 70mm | Withdrawn |
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
11 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | 510(k) number | 2014-01-22 | Class II | Manufacturing material removal | Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaft of the Malibu Polyaxial Drivers to break during use. None of the complaints reported a patient injury. However, some co | 40 | 2014-12-17 |
| Seaspine, Inc. | 510(k) number | 2009-03-04 | Not classified | Mixed-up of materials/components | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | 1,116 Screws in total | 2011-04-28 |
| Seaspine, Inc. | 510(k) number | 2009-03-04 | Not classified | Mixed-up of materials/components | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | 1,116 Screws in total | 2011-04-28 |
| Seaspine, Inc. | 510(k) number | 2009-03-04 | Not classified | Mixed-up of materials/components | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | 1,116 Screws in total | 2011-04-28 |
| Seaspine, Inc. | 510(k) number | 2009-03-04 | Not classified | Mixed-up of materials/components | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | 1,116 Screws in total | 2011-04-28 |
| Seaspine, Inc. | 510(k) number | 2009-03-04 | Not classified | Mixed-up of materials/components | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | 1,116 Screws in total | 2011-04-28 |
| Seaspine, Inc. | 510(k) number | 2009-03-04 | Not classified | Mixed-up of materials/components | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | 1,116 Screws in total | 2011-04-28 |
| Seaspine, Inc. | 510(k) number | 2009-03-04 | Not classified | Mixed-up of materials/components | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | 1,116 Screws in total | 2011-04-28 |
| Seaspine, Inc. | 510(k) number | 2009-03-04 | Not classified | Mixed-up of materials/components | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | 1,116 Screws in total | 2011-04-28 |
| Seaspine, Inc. | 510(k) number | 2009-03-04 | Not classified | Mixed-up of materials/components | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | 1,116 Screws in total | 2011-04-28 |
| Seaspine, Inc. | 510(k) number | 2009-03-04 | Not classified | Mixed-up of materials/components | SeaSpine has received reports relating to rust on the internal washer contained within the titanium seat assembly of certain Malibu Polyaxial and Malibu Reduction Screws. | 1,116 Screws in total | 2011-04-28 |
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.