Silverton® Spinal Fixation System

214 catalogue numbers from 7735-0530, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Interlaminal. 11 manufacturers in China are registered for this product code.

Registry build 21.09.26
11manufacturers in China registered for this device type
214catalogue numbers in this listing
1510(k) clearance

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.

Chinese manufacturers registered for FDA product code KWP
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

Regulatory record for Silverton® Spinal Fixation System
Listed by Biomet Spine, United States
FDA product code KWP
Device type Appliance, Fixation, Spinal Interlaminal
Device class Class 2
Regulation 21 CFR 888.3050
Record published 2020-06-27
Record revised 2025-07-02 (version 6)

Specifications

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

Catalogue Numbers

Catalogue numbers for Silverton® Spinal Fixation System
Catalogue number Size Status
7735-0530 Screw Assy Turret Osteo Ti Ø10.5x30mm In distribution
7735-6500 SCREW ASSY TURRET OSTEO TI Ø6.5X100MM In distribution
7731-8595 PEDICLE SCREW TURRET TI Ø8.5X95MM In distribution
7731-5540 PEDICLE SCREW TURRET TI Ø5.5X40MM In distribution
7738-4560 Ped Screw Dual Lead Assy Ti Ø4.5x60mm In distribution
7735-6590 SCREW ASSY TURRET OSTEO TI Ø6.5X90MM In distribution
7735-8580 Screw Assy Turret Osteo Ti Ø8.5x80mm In distribution
7702-1040 Cross Connector Variable Ti 40-45mm In distribution
7738-4520 PED SCREW DUAL LEAD ASSY TI Ø4.5X20MM In distribution
7727-7570 PEDICLE SCREW OSTEO TI Ø7.5X70MM In distribution
7738-4575 Ped Screw Dual Lead Assy Ti Ø4.5x75mm In distribution
7727-7540 PEDICLE SCREW OSTEO TI Ø7.5X40MM In distribution
7735-6585 Screw Assy Turret Osteo Ti Ø6.5x85mm In distribution
7735-9575 Screw Assy Turret Osteo Ti Ø9.5x75mm In distribution
7727-6550 PEDICLE SCREW OSTEO TI Ø6.5X50MM In distribution
7738-6580 Ped Screw Dual Lead Assy Ti Ø6.5x80mm In distribution
7712-6530 Pedicle Screw Osteo Ti Ø6.5x30mm In distribution
7735-8595 Screw Assy Turret Osteo Ti Ø8.5x95mm In distribution
7738-7540 Ped Screw Dual Lead Assy Ti Ø7.5x40mm In distribution
7712-8555 Pedicle Screw Osteo Ti Ø8.5x55mm In distribution
7727-5550 Pedicle Screw Osteo Ti Ø5.5x50mm In distribution
7738-7570 PED SCREW DUAL LEAD ASSY TI Ø7.5X70MM In distribution
7727-7530 Pedicle Screw Osteo Ti Ø7.5x30mm In distribution
7738-4565 PED SCREW DUAL LEAD ASSY TI Ø4.5X65MM In distribution
7735-7585 Screw Assy Turret Osteo Ti Ø7.5x85mm In distribution
7735-9585 Screw Assy Turret Osteo Ti Ø9.5x85mm In distribution
7738-8565 Ped Screw Dual Lead Assy Ti Ø8.5x65mm In distribution
7738-7535 PED SCREW DUAL LEAD ASSY TI Ø7.5X35MM In distribution
7738-8590 Ped Screw Dual Lead Assy Ti Ø8.5x90mm In distribution
7727-6585 Pedicle Screw Osteo Ti Ø6.5x85mm In distribution
7727-5580 Pedicle Screw Osteo Ti Ø5.5x80mm In distribution
7735-0560 SCREW ASSY TURRET OSTEO TI Ø10.5X60MM In distribution
7735-5565 Screw Assy Turret Osteo Ti Ø5.5x65mm In distribution
7738-5585 PED SCREW DUAL LEAD ASSY TI Ø5.5X85MM In distribution
7738-7555 PED SCREW DUAL LEAD ASSY TI Ø7.5X55MM In distribution
7735-8560 SCREW ASSY TURRET OSTEO TI Ø8.5X60MM In distribution
7731-8560 PEDICLE SCREW TURRET TI Ø8.5X60MM In distribution
7727-5535 Pedicle Screw Osteo Ti Ø5.5x35mm In distribution
7738-8535 Ped Screw Dual Lead Assy Ti Ø8.5x35mm In distribution
7735-5545 Screw Assy Turret Osteo Ti Ø5.5x45mm In distribution
7735-0560 Screw Assy Turret Osteo Ti Ø10.5x60mm In distribution
7738-8535 PED SCREW DUAL LEAD ASSY TI Ø8.5X35MM In distribution
7731-8535 PEDICLE SCREW TURRET TI Ø8.5X35MM In distribution
7731-4585 PEDICLE SCREW TURRET TI Ø4.5X85MM In distribution
7735-8500 SCREW ASSY TURRET OSTEO TI Ø8.5X100MM In distribution
7735-6530 Screw Assy Turret Osteo Ti Ø6.5x30mm In distribution
7738-7595 Ped Screw Dual Lead Assy Ti Ø7.5x95mm In distribution
7735-9525 SCREW ASSY TURRET OSTEO TI Ø9.5X25MM In distribution
7712-7540 Pedicle Screw Osteo Ti Ø7.5x40mm In distribution
7738-5550 PED SCREW DUAL LEAD ASSY TI Ø5.5X50MM In distribution
7712-5550 Pedicle Screw Osteo Ti Ø5.5x50mm In distribution
7731-7560 PEDICLE SCREW TURRET TI Ø7.5X60MM In distribution
7731-7530 Pedicle Screw Turret Ti Ø7.5x30mm In distribution
7738-7575 PED SCREW DUAL LEAD ASSY TI Ø7.5X75MM In distribution
7712-8560 Pedicle Screw Osteo Ti Ø8.5x60mm In distribution
7738-5555 PED SCREW DUAL LEAD ASSY TI Ø5.5X55MM In distribution
7735-6535 SCREW ASSY TURRET OSTEO TI Ø6.5X35MM In distribution
7735-6540 Screw Assy Turret Osteo Ti Ø6.5x40mm In distribution
7735-9525 Screw Assy Turret Osteo Ti Ø9.5x25mm In distribution
7738-7545 Ped Screw Dual Lead Assy Ti Ø7.5x45mm In distribution
7731-8580 Pedicle Screw Turret Ti Ø8.5x80mm In distribution
7735-6575 Screw Assy Turret Osteo Ti Ø6.5x75mm In distribution
7727-5575 PEDICLE SCREW OSTEO TI Ø5.5X75MM In distribution
7738-6565 Ped Screw Dual Lead Assy Ti Ø6.5x65mm In distribution
7738-7535 Ped Screw Dual Lead Assy Ti Ø7.5x35mm In distribution
7712-8530 Pedicle Screw Osteo Ti Ø8.5x30mm In distribution
7731-4575 Pedicle Screw Turret Ti Ø4.5x75mm In distribution
7731-7585 PEDICLE SCREW TURRET TI Ø7.5X85MM In distribution
7738-7550 PED SCREW DUAL LEAD ASSY TI Ø7.5X50MM In distribution
7738-6540 PED SCREW DUAL LEAD ASSY TI Ø6.5X40MM In distribution
7731-6590 PEDICLE SCREW TURRET TI Ø6.5X90MM In distribution
7731-6535 PEDICLE SCREW TURRET TI Ø6.5X35MM In distribution
7735-6535 Screw Assy Turret Osteo Ti Ø6.5x35mm In distribution
7738-7595 PED SCREW DUAL LEAD ASSY TI Ø7.5X95MM In distribution
7738-5550 Ped Screw Dual Lead Assy Ti Ø5.5x50mm In distribution
7731-6560 PEDICLE SCREW TURRET TI Ø6.5X60MM In distribution
7738-4540 PED SCREW DUAL LEAD ASSY TI Ø4.5X40MM In distribution
7731-7575 PEDICLE SCREW TURRET TI Ø7.5X75MM In distribution
7738-7520 PED SCREW DUAL LEAD ASSY TI Ø7.5X20MM In distribution
7731-8560 Pedicle Screw Turret Ti Ø8.5x60mm In distribution
7735-0500 SCREW ASSY TURRET OSTEO TI Ø10.5X100MM In distribution
7727-6535 Pedicle Screw Osteo Ti Ø6.5x35mm In distribution
7735-6595 Screw Assy Turret Osteo Ti Ø6.5x95mm In distribution
7731-6545 PEDICLE SCREW TURRET TI Ø6.5X45MM In distribution
7731-6560 Pedicle Screw Turret Ti Ø6.5x60mm In distribution
7727-7500 Pedicle Screw Osteo Ti Ø7.5x100mm In distribution
7712-5525 Pedicle Screw Osteo Ti Ø5.5x25mm In distribution
7738-4590 Ped Screw Dual Lead Assy Ti Ø4.5x90mm In distribution
7712-5575 Pedicle Screw Osteo Ti Ø5.5x75mm In distribution
7731-7550 PEDICLE SCREW TURRET TI Ø7.5X50MM In distribution
7731-4555 Pedicle Screw Turret Ti Ø4.5x55mm In distribution
7735-0570 Screw Assy Turret Osteo Ti Ø10.5x70mm In distribution
7712-8525 Pedicle Screw Osteo Ti Ø8.5x25mm In distribution
7735-8535 Screw Assy Turret Osteo Ti Ø8.5x35mm In distribution
7731-5570 Pedicle Screw Turret Ti Ø5.5x70mm In distribution
7738-8570 Ped Screw Dual Lead Assy Ti Ø8.5x70mm In distribution
7738-5520 Ped Screw Dual Lead Assy Ti Ø5.5x20mm In distribution
7735-8525 Screw Assy Turret Osteo Ti Ø8.5x25mm In distribution
7712-7520 Pedicle Screw Osteo Ti Ø7.5x20mm In distribution
7735-5575 SCREW ASSY TURRET OSTEO TI Ø5.5X75MM In distribution
7738-7525 PED SCREW DUAL LEAD ASSY TI Ø7.5X25MM In distribution
7712-6555 Pedicle Screw Osteo Ti Ø6.5x55mm In distribution
7712-6540 Pedicle Screw Osteo Ti Ø6.5x40mm In distribution
7735-7555 SCREW ASSY TURRET OSTEO TI Ø7.5X50MM In distribution
7738-7550 Ped Screw Dual Lead Assy Ti Ø7.5x50mm In distribution
7738-8585 PED SCREW DUAL LEAD ASSY TI Ø8.5X85MM In distribution
7738-5590 Ped Screw Dual Lead Assy Ti Ø5.5x90mm In distribution
7738-6540 Ped Screw Dual Lead Assy Ti Ø6.5x40mm In distribution
7738-7500 Ped Screw Dual Lead Assy Ti Ø7.5x100mm In distribution
7731-8500 PEDICLE SCREW TURRET TI Ø8.5X100MM In distribution
7731-5500 Pedicle Screw Turret Ti Ø5.5x100mm In distribution
7735-0595 Screw Assy Turret Osteo Ti Ø10.5x95mm In distribution
7735-8555 Screw Assy Turret Osteo Ti Ø8.5x50mm In distribution
7738-4520 Ped Screw Dual Lead Assy Ti Ø4.5x20mm In distribution
7738-6530 Ped Screw Dual Lead Assy Ti Ø6.5x30mm In distribution
7702-1040 CROSS CONNECTOR VARIABLE TI 40-45MM In distribution
7738-8500 PED SCREW DUAL LEAD ASSY TI Ø8.5X100MM In distribution
7738-8570 PED SCREW DUAL LEAD ASSY TI Ø8.5X70MM In distribution
7727-5500 Pedicle Screw Osteo Ti Ø5.5x100mm In distribution
7738-7580 Ped Screw Dual Lead Assy Ti Ø7.5x80mm In distribution
7731-6565 PEDICLE SCREW TURRET TI Ø6.5X65MM In distribution
7731-4500 Pedicle Screw Turret Ti Ø4.5x100mm In distribution
7738-6565 PED SCREW DUAL LEAD ASSY TI Ø6.5X65MM In distribution
7712-5555 Pedicle Screw Osteo Ti Ø5.5x55mm In distribution
7727-5565 PEDICLE SCREW OSTEO TI Ø5.5X65MM In distribution
7738-7560 PED SCREW DUAL LEAD ASSY TI Ø7.5X60MM In distribution
7738-7530 Ped Screw Dual Lead Assy Ti Ø7.5x30mm In distribution
7735-5555 Screw Assy Turret Osteo Ti Ø5.5x50mm In distribution
7738-7555 Ped Screw Dual Lead Assy Ti Ø7.5x55mm In distribution
7735-0565 SCREW ASSY TURRET OSTEO TI Ø10.5X65MM In distribution
7738-5590 PED SCREW DUAL LEAD ASSY TI Ø5.5X90MM In distribution
7738-8580 Ped Screw Dual Lead Assy Ti Ø8.5x80mm In distribution
7731-5580 PEDICLE SCREW TURRET TI Ø5.5X80MM In distribution
7731-8550 Pedicle Screw Turret Ti Ø8.5x50mm In distribution
7738-6575 Ped Screw Dual Lead Assy Ti Ø6.5x75mm In distribution
7702-1128 CROSS CONNECTOR FIXED TI 28MM In distribution
7738-5545 Ped Screw Dual Lead Assy Ti Ø5.5x45mm In distribution
7738-5595 Ped Screw Dual Lead Assy Ti Ø5.5x95mm In distribution
7727-6565 Pedicle Screw Osteo Ti Ø6.5x65mm In distribution
7738-4550 Ped Screw Dual Lead Assy Ti Ø4.5x50mm In distribution
7727-6535 PEDICLE SCREW OSTEO TI Ø6.5X35MM In distribution
7731-5560 PEDICLE SCREW TURRET TI Ø5.5X60MM In distribution
7731-8530 PEDICLE SCREW TURRET TI Ø8.5X30MM In distribution
7735-9540 SCREW ASSY TURRET OSTEO TI Ø9.5X40MM In distribution
7738-8550 Ped Screw Dual Lead Assy Ti Ø8.5x50mm In distribution
7735-7575 SCREW ASSY TURRET OSTEO TI Ø7.5X75MM In distribution
7738-4590 PED SCREW DUAL LEAD ASSY TI Ø4.5X90MM In distribution
7735-8595 SCREW ASSY TURRET OSTEO TI Ø8.5X95MM In distribution
7738-8545 PED SCREW DUAL LEAD ASSY TI Ø8.5X45MM In distribution
7731-4580 PEDICLE SCREW TURRET TI Ø4.5X80MM In distribution
7738-5575 PED SCREW DUAL LEAD ASSY TI Ø5.5X75MM In distribution
7712-7535 Pedicle Screw Osteo Ti Ø7.5x35mm In distribution
7738-6545 PED SCREW DUAL LEAD ASSY TI Ø6.5X45MM In distribution
7727-7575 Pedicle Screw Osteo Ti Ø7.5x75mm In distribution
7727-5595 Pedicle Screw Osteo Ti Ø5.5x95mm In distribution
7712-6560 Pedicle Screw Osteo Ti Ø6.5x60mm In distribution
7731-8500 Pedicle Screw Turret Ti Ø8.5x100mm In distribution
7731-4575 PEDICLE SCREW TURRET TI Ø4.5X75MM In distribution
7712-8580 Pedicle Screw Osteo Ti Ø8.5x80mm In distribution
7727-6595 Pedicle Screw Osteo Ti Ø6.5x95mm In distribution
7738-8575 PED SCREW DUAL LEAD ASSY TI Ø8.5X75MM In distribution
7727-6590 Pedicle Screw Osteo Ti Ø6.5x90mm In distribution
7731-8565 Pedicle Screw Turret Ti Ø8.5x65mm In distribution
7735-9540 Screw Assy Turret Osteo Ti Ø9.5x40mm In distribution
7731-5580 Pedicle Screw Turret Ti Ø5.5x80mm In distribution
7712-7580 Pedicle Screw Osteo Ti Ø7.5x80mm In distribution
7738-4525 Ped Screw Dual Lead Assy Ti Ø4.5x25mm In distribution
7738-5560 PED SCREW DUAL LEAD ASSY TI Ø5.5X60MM In distribution
7738-6545 Ped Screw Dual Lead Assy Ti Ø6.5x45mm In distribution
7731-7585 Pedicle Screw Turret Ti Ø7.5x85mm In distribution
7735-5585 SCREW ASSY TURRET OSTEO TI Ø5.5X85MM In distribution
7735-6580 Screw Assy Turret Osteo Ti Ø6.5x80mm In distribution
7738-8555 Ped Screw Dual Lead Assy Ti Ø8.5x55mm In distribution
7731-6575 PEDICLE SCREW TURRET TI Ø6.5X75MM In distribution
7735-7530 Screw Assy Turret Osteo Ti Ø7.5x30mm In distribution
7712-5580 Pedicle Screw Osteo Ti Ø5.5x80mm In distribution
7738-4570 Ped Screw Dual Lead Assy Ti Ø4.5x70mm In distribution
7735-7540 SCREW ASSY TURRET OSTEO TI Ø7.5X40MM In distribution
7731-7565 Pedicle Screw Turret Ti Ø7.5x65mm In distribution
7727-7525 PEDICLE SCREW OSTEO TI Ø7.5X25MM In distribution
7738-6595 PED SCREW DUAL LEAD ASSY TI Ø6.5X95MM In distribution
7727-6530 Pedicle Screw Osteo Ti Ø6.5x30mm In distribution
7735-6525 SCREW ASSY TURRET OSTEO TI Ø6.5X25MM In distribution
7731-5530 Pedicle Screw Turret Ti Ø5.5x30mm In distribution
7735-0540 Screw Assy Turret Osteo Ti Ø10.5x40mm In distribution
7738-6585 Ped Screw Dual Lead Assy Ti Ø6.5x85mm In distribution
7712-8585 Pedicle Screw Osteo Ti Ø8.5x85mm In distribution
7735-5585 Screw Assy Turret Osteo Ti Ø5.5x85mm In distribution
7738-8585 Ped Screw Dual Lead Assy Ti Ø8.5x85mm In distribution
7738-8530 Ped Screw Dual Lead Assy Ti Ø8.5x30mm In distribution
7738-6550 PED SCREW DUAL LEAD ASSY TI Ø6.5X50MM In distribution
7712-5560 Pedicle Screw Osteo Ti Ø5.5x60mm In distribution
7738-8560 Ped Screw Dual Lead Assy Ti Ø8.5x60mm In distribution
7738-5530 PED SCREW DUAL LEAD ASSY TI Ø5.5X30MM In distribution
7735-9580 Screw Assy Turret Osteo Ti Ø9.5x80mm In distribution
7712-7530 Pedicle Screw Osteo Ti Ø7.5x30mm In distribution
7738-6500 Ped Screw Dual Lead Assy Ti Ø6.5x100mm In distribution
7735-7590 Screw Assy Turret Osteo Ti Ø7.5x90mm In distribution
7712-5595 Pedicle Screw Osteo Ti Ø5.5x95mm In distribution
7735-6570 Screw Assy Turret Osteo Ti Ø6.5x70mm In distribution
7735-5550 Screw Assy Turret Osteo Ti Ø5.5x45mm In distribution
7738-6560 PED SCREW DUAL LEAD ASSY TI Ø6.5X60MM In distribution
7735-9560 SCREW ASSY TURRET OSTEO TI Ø9.5X60MM In distribution
7735-9570 Screw Assy Turret Osteo Ti Ø9.5x70mm In distribution
7731-6590 Pedicle Screw Turret Ti Ø6.5x90mm In distribution
7738-6595 Ped Screw Dual Lead Assy Ti Ø6.5x95mm In distribution
7712-7590 Pedicle Screw Osteo Ti Ø7.5x90mm In distribution
7738-6590 Ped Screw Dual Lead Assy Ti Ø6.5x90mm In distribution
7738-8540 PED SCREW DUAL LEAD ASSY TI Ø8.5X40MM In distribution
7735-6525 Screw Assy Turret Osteo Ti Ø6.5x25mm In distribution
7727-6585 PEDICLE SCREW OSTEO TI Ø6.5X85MM In distribution
7738-4530 PED SCREW DUAL LEAD ASSY TI Ø4.5X30MM In distribution
7738-4570 PED SCREW DUAL LEAD ASSY TI Ø4.5X70MM In distribution
7731-4530 Pedicle Screw Turret Ti Ø4.5x30mm In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
Clearance Decision date
K071377 2007-08-06

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer