UCR
Polyaxial Reduction Screw 4.75 x 35 mm
11manufacturers in China registered for this device type
62catalogue numbers in this listing
3510(k) clearances naming this product code
10recalls on this code
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 | Seaspine, Inc., United States |
|---|---|
| FDA product code | KWP |
| Device type | Appliance, Fixation, Spinal Interlaminal |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3050 |
| Record published | 2014-09-18 |
| Record revised | 2025-07-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2015-11-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-8060 | 8.0 x 60 mm | Withdrawn |
| 10-6050 | 6.0 x 50 mm | Withdrawn |
| 10-5525 | 5.5 x 25 mm | Withdrawn |
| 11-6025 | 6.0 x 25 mm | Withdrawn |
| 10-6730 | 6.75 x 30 mm | Withdrawn |
| 10-6030 | 6.0 x 30 mm | Withdrawn |
| 11-8040 | 8.0 x 40mm | Withdrawn |
| 10-8045 | 8.0 x 45 mm | Withdrawn |
| 11-4735 | 4.75 x 35 mm | Withdrawn |
| 10-6760 | 6.75 x 60 mm | Withdrawn |
| 11-5540 | 5.5 x 40 mm | Withdrawn |
| 11-4750 | 4.75 x 50 mm | Withdrawn |
| 10-6025 | 6.0 x 25 mm | Withdrawn |
| 11-6735 | 6.75 x 35 mm | Withdrawn |
| 10-5545 | 5.5 x 45 mm | Withdrawn |
| 10-4750 | 4.75 x 50 mm | Withdrawn |
| 10-5530 | 5.5 x 30 mm | Withdrawn |
| 11-5545 | 5.5 x 45 mm | Withdrawn |
| 11-4740 | 4.75 x 40 mm | Withdrawn |
| 11-6030 | 6.0 x 30 mm | Withdrawn |
| 11-4725 | 4.75 x 25 mm | Withdrawn |
| 11-5530 | 5.5 x 30 mm | Withdrawn |
| 10-6040 | 6.0 x 40 mm | Withdrawn |
| 10-4740 | 4.75 x 40 mm | Withdrawn |
| 11-4730 | 4.75 x 30 mm | Withdrawn |
| 10-6740 | 6.75 x 40 mm | Withdrawn |
| 10-4745 | 4.75 x 45 mm | Withdrawn |
| 10-5550 | 5.5 x 50 mm | Withdrawn |
| 10-6060 | 6.0 x 60 mm | Withdrawn |
| 10-4735 | 4.75 x 35 mm | Withdrawn |
| 10-4730 | 4.75 x 30 mm | Withdrawn |
| 10-6745 | 6.75 x 45 mm | Withdrawn |
| 10-8050 | 8.0 x 50 mm | Withdrawn |
| 11-5525 | 5.5 x 25 mm | Withdrawn |
| 11-4745 | 4.75 x 45 mm | Withdrawn |
| 10-6735 | 6.75 x 35 mm | Withdrawn |
| 11-6035 | 6.0 x 35 mm | Withdrawn |
| 10-4755 | 4.75 x 55 mm | Withdrawn |
| 11-6060 | 6.0 x 60 mm | Withdrawn |
| 11-8030 | 8.0 x 30mm | Withdrawn |
| 10-8055 | 8.0 x 55 mm | Withdrawn |
| 10-6045 | 6.0 x 45 mm | Withdrawn |
| 10-6755 | 6.75 x 55 mm | Withdrawn |
| 10-5540 | 5.5 x 40 mm | Withdrawn |
| 11-5550 | 5.5 x 50 mm | Withdrawn |
| 10-8030 | 8.0 x 30 mm | Withdrawn |
| 10-6035 | 6.0 x 35 mm | Withdrawn |
| 10-6055 | 6.0 x 55 mm | Withdrawn |
| 11-6745 | 6.75 x 45 mm | Withdrawn |
| 11-8050 | 8.0 x 50mm | Withdrawn |
| 11-6050 | 6.0 x 50 mm | Withdrawn |
| 10-8035 | 8.0 x 35 mm | Withdrawn |
| 10-5555 | 5.5 x 55 mm | Withdrawn |
| 11-8055 | 8.0 x 55mm | Withdrawn |
| 10-5535 | 5.5 x 35 mm | Withdrawn |
| 10-8040 | 8.0 x 40 mm | Withdrawn |
| 11-5535 | 5.5 x 35 mm | Withdrawn |
| 11-4755 | 4.75 x 55 mm | Withdrawn |
| 10-6750 | 6.75 x 50 mm | Withdrawn |
| 11-6755 | 6.75 x 55 mm | Withdrawn |
| 10-4725 | 4.75 x 25 mm | Withdrawn |
| 11-5555 | 5.5 x 55 mm | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K072729 | 2008-04-17 |
| K080526 | 2008-04-16 |
| K051942 | 2005-07-27 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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.