Appliance, Fixation, Spinal Intervertebral Body

Which Manufacturers in China Make This?

8 of the 14 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Jiangsu, Shanghai and Shandong, and 3 other provinces.

APS Materials Suzhou Jiangsu, contract manufacturer
Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
Changzhou Biomet Medical Devices Co., Ltd. Jiangsu, contract manufacturer
Double Medical Technology Inc. Fujian, contract manufacturer
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Jiangsu
LX Precision Shanghai Co Ltd Shanghai, contract manufacturer
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Jiangsu
Paragon Medical Device (Changzhou) Co., Ltd. Jiangsu, contract manufacturer
Shandong Weigao Orthopaedic Device Co., Ltd. Shandong, contract manufacturer
Shanghai JPY ION-Tech Co., Ltd. Shanghai, contract manufacturer
Shanghai Sanyou Medical Co., Ltd. Shanghai
Zhejiang Decans Medical Devices Co., Ltd. Zhejiang
Zibo Dante Co., Ltd. Shandong, contract manufacturer
Zhejiang Biomet Medical Products Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code KWQ?

Appliance, Fixation, Spinal Intervertebral Body is FDA product code KWQ, Class 2, 21 CFR 888.3060.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 4 clearances under this code; the FDA took a median of 172 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 214 recalls under this product code since 2002. None was by a company in China. The root causes the FDA records most often are Device Design (77), Nonconforming Material/Component (9) and Error in labeling (8).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Appliance, Fixation, Spinal Intervertebral Body

Polaris 5.5 SST Spine SYS

62 catalogue numbers from 14-506785, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Spine System

61 catalogue numbers from 14-501310, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Trinica® Trinica®

90 catalogue numbers from 07.00119.009, listed by Zimmer Spine, Inc., United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

LnK Acterior Cervical Plate

L&K Biomed Cervical plate screw(Self-Drilling Variable type) 3.5x17mm 1EA

Appliance, Fixation, Spinal Intervertebral Body

StruXure

StruXure Locking Cap, Dual Screw Single

Appliance, Fixation, Spinal Intervertebral Body

Cequence Anterior Cervical Plate

Cequence Middle Holes Double Barrel Drill Guide W/Adjustable Handle

Appliance, Fixation, Spinal Intervertebral Body

Union MAX

The variable screw in the uNion MAX range is a titanium alloy component used with anterior cervical plates. The construct provides mechanical support across treated cervical levels until…

Appliance, Fixation, Spinal Intervertebral Body

Athena II Cervical Plate System

Athena II Screw - Self Drilling Ø4.0x19mm

Appliance, Fixation, Spinal Intervertebral Body

Admiral

4.3mm Variable Angle Screw, Self-Drilling, 15mm

Appliance, Fixation, Spinal Intervertebral Body

Stainless Steel

Hex End Straight Rod, Stainless Steel, 500mm. The Stainless Steel Spinal System consists of a variety of types and sizes of rods, hooks, screws. The Stainless Steel Spinal System implant…

Appliance, Fixation, Spinal Intervertebral Body

Optima™ Spinal System

265 catalogue numbers from SG1801, listed by CG MedTech Co., Ltd., South Korea, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Zephir® Anterior Cervical System

Screw X0706213 ZEP-Self DRILL-D4.5-L15MM

Appliance, Fixation, Spinal Intervertebral Body

Monaco Pedicle Screw System

Solid Polyaxial Iliac Deformity Screw, Monaco

Appliance, Fixation, Spinal Intervertebral Body

Cyclops Anterior Cervical Plate System

Screw, Self Drilling, 4.25, Variable

Appliance, Fixation, Spinal Intervertebral Body

Gradient

Gradient Plate, 100mm Fixed 5-Level

Appliance, Fixation, Spinal Intervertebral Body

Polaris 4.75 TI Spinal System

201 catalogue numbers from 14-589675, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Vail OCT Spinal Fixation System

125 catalogue numbers from 7904-4022, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Active™

ACP 4 Level x 109mm, Active

Appliance, Fixation, Spinal Intervertebral Body

Zion

ACS, Self Drilling, Variable, 4.0MM-19MM

Appliance, Fixation, Spinal Intervertebral Body

Snowcap® Anterior Cervical Plate System

266 catalogue numbers from 4432-2422, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

GSO ACP1 Anterior Cervical Plate System

Variable Angle Screw

Appliance, Fixation, Spinal Intervertebral Body

PAC Plate Anterior Cervical Plate System

Cervical Screw, Variable Self-Drilling

Appliance, Fixation, Spinal Intervertebral Body

Cayman® Plate System

Screw, Self Starting Size Ø5.0 x 28 mm

Appliance, Fixation, Spinal Intervertebral Body

Divergence™ Anterior Cervical Fusion System

Implant G7736542 MP Lordo 12MMX15MMX14MM

Appliance, Fixation, Spinal Intervertebral Body

Buttress

Anterior Buttress Plate and Screw Caddy Lid

Appliance, Fixation, Spinal Intervertebral Body

Preference Pedicle Screw System

Pedicle Blocker Standard (for use with 4.5mm - 7.2mm screws)

Appliance, Fixation, Spinal Intervertebral Body

InCompass®

62 catalogue numbers from 2206-8590, listed by Zimmer Spine, Inc., United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Eagle

EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 12.5mm

Appliance, Fixation, Spinal Intervertebral Body

Anterior Cervical Plate

4.00mm x 18mm Binary Auger Tip Variable Screw

Appliance, Fixation, Spinal Intervertebral Body

Excella III-D®

59 catalogue numbers from UCL2525, listed by Inno-Health Technology Co., Ltd., Taiwan, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Trestle Luxe

ANTERIOR CERVICAL PLATE MEDIAL TEMP TACK ASSEMBLY, 3-LEVEL, 060mm

Appliance, Fixation, Spinal Intervertebral Body

CarboClear Cervical Plate System

CarboClear Cervical Plate System provides anterior fixation of the cervical spine while a fusion develops. It combines plates, screws and instruments in a range of dimensions. The plates…

Appliance, Fixation, Spinal Intervertebral Body

Seculok™ ACP System

51 catalogue numbers from FCA1031, listed by CG MedTech Co., Ltd., South Korea, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Ant-Cer II®

40 catalogue numbers from 1777-13, listed by Zimmer Spine, Inc., United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Elatus Lumbar Plate System

Variable Lumbar Plate Screw Dual Thread Ø 5.5x 30mm

Appliance, Fixation, Spinal Intervertebral Body

Slimplicity Plus Anterior Cervical Plating System

Slimplicity® Plus Self Drilling Screw Caddy (Empty)

Appliance, Fixation, Spinal Intervertebral Body

Acumen Thoracolumbar Plate System

Acumen, THORACOLUMBAR PLATE, FOUR HOLE, SACRAL WITH RIDGE, FLAT, 20mm

Appliance, Fixation, Spinal Intervertebral Body

Reliant

108MM Four Level Cervical Plate Assembly, Reliant Acps

Appliance, Fixation, Spinal Intervertebral Body

Aspiron™ Acpsystem

132 catalogue numbers from NC4018FT, listed by CG MedTech Co., Ltd., South Korea, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Sapphire

SAPPHIRE® Dia. 4.0 x 20mm Self-Tapping Variable-Angle Screw

Appliance, Fixation, Spinal Intervertebral Body

Antegra

TI Antegra(TM) Plate TWO Level LUMBAR/103MM

Appliance, Fixation, Spinal Intervertebral Body

ABC

ABC Self-Locking Revision Screw 4.5X17MM

Appliance, Fixation, Spinal Intervertebral Body

Aviator

Variable, Self-Drilling Screw

Appliance, Fixation, Spinal Intervertebral Body

Struxxure™ Anterior Cervical Plate and Screws

Struxxure Self-Drilling Screw Caddy, Variable, Even

Appliance, Fixation, Spinal Intervertebral Body

Lumbar Plate

1 Level Lumbar Plate Four Bore Drill Guide 34mm Orthogonal

Appliance, Fixation, Spinal Intervertebral Body

Excella MIS™

14 catalogue numbers from MSR5535, listed by Inno-Health Technology Co., Ltd., Taiwan, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Fortis ACP

Fortis Variable Angle Screw (Self_Tapping Rounded Tip) (L1)14x(L2)16.9x(D)4.5mm-Light Blue #35

Appliance, Fixation, Spinal Intervertebral Body

Iris Anterior Cervical Plate System

Fixed Angle Double Barrel Drill Guide - 0 degree Intermediat

Appliance, Fixation, Spinal Intervertebral Body

King Cobra

King Cobra is an anterior cervical plate system used as an adjunct to spinal fusion from C2 to C7. Plates and self-tapping screws form a fixation construct that stabilizes the cervical…

Appliance, Fixation, Spinal Intervertebral Body

V2F™

37 catalogue numbers from 07.01657.010, listed by Zimmer Spine, Inc., United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Aclp

TI Anterior Cervical Locking Plate 4 LEVEL/100MM

Appliance, Fixation, Spinal Intervertebral Body

Cslp

TI Cervical Spine Locking PL Variable Angle 4 LEVEL/100MM

Appliance, Fixation, Spinal Intervertebral Body

Golden Gate™ Anterior Plate System

golden gate screw, polyaxial, length 40 mm cannulated

Appliance, Fixation, Spinal Intervertebral Body

SlimLine®

115 catalogue numbers from 404-2036, listed by Zimmer Spine, Inc., United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Assure

ASSURE Translational Cervical Plate 4-Level, 100mm

Appliance, Fixation, Spinal Intervertebral Body

Brigade

Brigade Plate Pin, 12mm Ø.080 Fixation

Appliance, Fixation, Spinal Intervertebral Body

Valiant™ Anterior Lumbar Plate System

53 catalogue numbers from 14-530207, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Truss

TRUSS Compression Plate, 62-69.5mm

Appliance, Fixation, Spinal Intervertebral Body

Czar Anterior Cervical Plate System 3 Level

11 catalogue numbers from 60030069, listed by Met 1 Technologies, LLC, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Regent

Regent ACP Self Drilling Variable Screw 4.0 x 18mm

Appliance, Fixation, Spinal Intervertebral Body

Impeace Cervical Plate System

Variable-angle screws (self-drilling Aggressive), Ø4.5, 16mm

Appliance, Fixation, Spinal Intervertebral Body

Union Cervical Plate System

Implant Module #5 Screw Caddy - 4.0 Combo Self Drill/Tapping & 4.5mm Screws

Appliance, Fixation, Spinal Intervertebral Body

LAT-Fuse™* Lateral Plate System

Screw Inserter, Self-Retained

Appliance, Fixation, Spinal Intervertebral Body

Hyper-C Anterior Cervical Plate System

Hyper-C is an anterior cervical plate-and-screw system for temporary stabilization while spinal fusion develops. Its plates connect to the vertebrae through bone screws placed from the…

Appliance, Fixation, Spinal Intervertebral Body

U.l.i.s.™

U.L.I.S.™ multi-axial reduction screw 4.5mm x 40mm

Appliance, Fixation, Spinal Intervertebral Body

FortiBridge

FortiBridge Anterior Cervical Plate 1 level 12mm ACP

Appliance, Fixation, Spinal Intervertebral Body

Gateway

GATEWAY Thoracolumbar Plate, 100mm

Appliance, Fixation, Spinal Intervertebral Body

Medtronic Resuable Instruments

Freehand Holder 9877701 Lordotic 3-HOLE

Appliance, Fixation, Spinal Intervertebral Body

Icotec Anterior Cervical Plate System, Template for 4 Segmental Plate 82 Mm

icotec Anterior Cervical Plate System, Template/Fixation Pin Holder, SW 4 mm

Appliance, Fixation, Spinal Intervertebral Body

Sapphire X3

Ø3.5MM X 11MM Self-Drilling,variable Angle Screw

Appliance, Fixation, Spinal Intervertebral Body

Macs TL

Macs TL HMA Polyaxial Screw 12X26MM Grey

Appliance, Fixation, Spinal Intervertebral Body

Kaneda SR

KANEDA SR ANTERIOR SYSTEM BLUNT TIP CLOSED SCREW 6.35 x 6.25 x 35mm

Appliance, Fixation, Spinal Intervertebral Body

Altum

ALTUM Anterior Cervical Plate - 1 Level, 18mm Long

Appliance, Fixation, Spinal Intervertebral Body

Icotec Spine System, Screw Self-Tap, Ø 4.0 X 15 Mm

Catalogue number 12-70-40-153, listed by Icotec AG, Switzerland, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Polaris 5.5 TI Spinal System

60 catalogue numbers from 14-578380R, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Polaris 6.35 Spinal System

280 catalogue numbers from 53-6116MP, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

SpheRx

SpheRx II Anterior Connector, 14mm Fixed

Appliance, Fixation, Spinal Intervertebral Body

Xlif Decade Plate

XLIF Decade Plate Bolt, 5.5x35mm Large

Appliance, Fixation, Spinal Intervertebral Body

Cure 2.0 ACP

CERVICAL VARIABLE SELF DRILLING SCREW (x2) Ø4.1 L12

Appliance, Fixation, Spinal Intervertebral Body

Aspida

Alif Screw, 7.0MM X 35MM

Appliance, Fixation, Spinal Intervertebral Body

Slimplicity Anterior Cervical Plate System

Slimplicity ACP Sterilization Case (Empty)

Appliance, Fixation, Spinal Intervertebral Body

Velox

VELOX ACP Variable Angle Cervical Screw DIA.4.5mm 16mm

Appliance, Fixation, Spinal Intervertebral Body

Trinica®

119 catalogue numbers from 07.01012.003, listed by Zimmer Spine, Inc., United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

C-Tek® Anterior Cervical Plate

119 catalogue numbers from 1100-2010B, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Traverse

Traverse Plate, Size 105 Compression

Appliance, Fixation, Spinal Intervertebral Body

Quintex

Quintex Semiconstrained Screw 4.0X14MM

Appliance, Fixation, Spinal Intervertebral Body

Elegance® Anterior Cervical Plate

The self-drilling variable screw in the Elegance Anterior Cervical Plate range is a bone screw used with anterior cervical plates. The system fixes the cervical spine from C2 to C7, with…

Appliance, Fixation, Spinal Intervertebral Body

C-TEK® Maxan®

76 catalogue numbers from 14-521619, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Meridian

Anterior Plate Locking Cover, 14mm, Backup

Appliance, Fixation, Spinal Intervertebral Body

XIA 4 5

Vitallium Prebent AND Precut ROD Without HEX

Appliance, Fixation, Spinal Intervertebral Body

Cabo™

Variable - 4.0mm Self Drilling 16mm

Appliance, Fixation, Spinal Intervertebral Body

Contact ALP

6.0 X 22 Lumbar Screw Assembly

Appliance, Fixation, Spinal Intervertebral Body

Cassiopeia Cervical Plate System

The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments. The CASSIOPEIA Cervical…

Appliance, Fixation, Spinal Intervertebral Body

Liberty Anterior Cervical Plate

Variable Screw, Self Drilling, 4.0x15mm

Appliance, Fixation, Spinal Intervertebral Body

Rhausler

Bicortical Self Tapping Locking Screws,4.0x18mm,Silver, Single Use Only

Appliance, Fixation, Spinal Intervertebral Body

Aesculap

ABC E-PLATE Integration Forceps, non-sterile, reusable, to be used with: FJ886R, FJ887R, FJ892R

Appliance, Fixation, Spinal Intervertebral Body

Skyline

SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-DRILLING SCREW 4.0 x 14mm

Appliance, Fixation, Spinal Intervertebral Body

Vuelock® Anterior Cervical Plate System

216 catalogue numbers from 63061, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Anterior Cervical Stabilization System (Ssacss), Kwik-Fix/TS® Cervical System

Awl Handle, Shaft, Spring, and Cap (without sleeve)

Appliance, Fixation, Spinal Intervertebral Body

Athena III Cervical Plate System

Atena III Screw - Self Drilling Ø4.0x15mm

Appliance, Fixation, Spinal Intervertebral Body

Streamline®* TL Spinal Fixation System

Pedicle Screw, Polyaxial, Cannulated, Reduction 7.5mm (D) 95mm (L)

Appliance, Fixation, Spinal Intervertebral Body

Cypher™ MIS System

134 catalogue numbers from 14-571037, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

Helios

3 Level Anterior Cervical Plate

Appliance, Fixation, Spinal Intervertebral Body

Spira®-A Integrated

5.5mm, Variable Angle, Self-Drilling Bone Screw, 45mm

Appliance, Fixation, Spinal Intervertebral Body

Anodyne Plate System

Anodyne-Single Cervical Screw - Variable Self Drilling - 5.2MM X 16MM

Appliance, Fixation, Spinal Intervertebral Body

inViZia®

inVizia® Double Barrel Drill Guide, Variable

Appliance, Fixation, Spinal Intervertebral Body

NexGen Anterior Cervical Plate System

Slimplicity HP Implant & Instrument Large Handle Kit

Appliance, Fixation, Spinal Intervertebral Body

Corra

corra™, Cervical Anterior Segmental Plate, 2 Hole Right, C81 Plan

Appliance, Fixation, Spinal Intervertebral Body

TiLock

8.5mm x 100mm Modular Cannulated Single Thread Screw

Appliance, Fixation, Spinal Intervertebral Body

Zavation ROD Connector

ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 12mm offset,4.75/5.5mm X 4.75/5.5mm

Appliance, Fixation, Spinal Intervertebral Body

MaxAn Anterior Cervical Plate System

4.5 X20MM Blunt Variable Screw

Appliance, Fixation, Spinal Intervertebral Body

Segmental Plating System

Segmental Plating System is an anterior cervical plate-and-screw construct. Titanium-alloy plates with two to four holes accept 3.5 or 4.0 mm screws to stabilize the cervical spine. The…

Appliance, Fixation, Spinal Intervertebral Body

Vitality®

601 catalogue numbers from 702M9580, listed by Biomet Spine, United States, under Appliance, Fixation, Spinal Intervertebral Body. 14 manufacturers in China are registered for this product code.

Appliance, Fixation, Spinal Intervertebral Body

ACP

ACP Hybrid Screw, 4.0x17mm S.T. Variable

Appliance, Fixation, Spinal Intervertebral Body

Preference 2

Caddie pedicle Locking Cap Standard and Large, Complex Spine

Appliance, Fixation, Spinal Intervertebral Body

Pulse

PULSE LUMBAR SCREW SYSTEM PRE-LORDOSED ROD 5.5 x 65mm

Appliance, Fixation, Spinal Intervertebral Body

Isola

ANTERIOR ISOLA SPINE SYSTEM CLOSED SCREW 4.75 x 4.75 x 70mm

Appliance, Fixation, Spinal Intervertebral Body

Venus

Venus Cervical Screw, Variable, 4.0 x 12mm Long, Blunt

Appliance, Fixation, Spinal Intervertebral Body

REX

Rex Cervical Plate System - ACP Variable Self Tapping Screw - Cross Type (L1)12x(L2)3.5mm-LightGreen

Appliance, Fixation, Spinal Intervertebral Body

4WEB Medical

CSTS-PLT357-NS

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