Stalif C

STALIF C is a cervical interbody fusion cage that combines a radiolucent PEEK body with titanium alloy bone screws. It is placed in the disc space between adjacent vertebral bodies and used…

Registry build 21.09.26

STALIF C is a cervical interbody fusion cage that combines a radiolucent PEEK body with titanium alloy bone screws. It is placed in the disc space between adjacent vertebral bodies and used as a standalone construct without additional supplemental fixation.

The cage’s outline follows the vertebral endplate, and its central cavity is packed with the patient’s own bone graft. Unalloyed tantalum marker wires make the cage position visible on radiographs.

Fusion Construct

The PEEK-OPTIMA LT1 cage and its unicortical cancellous-bone screws work together as the fusion device. STALIF C is intended for a single cervical level from C2 to T1 in skeletally mature patients with cervical degenerative disc disease.

5manufacturers in China registered for this device type
58catalogue numbers in this listing
4510(k) clearances naming this product code

Who Else Makes It

Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OVE
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Zhisu Health Tech Jiaxing Co., Ltd. Tongxiang Zhejiang Contract manufacturer 4
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Zhejiang Decans Medical Devices Co., Ltd. Jiaxing Zhejiang Manufacturer 10

Record

Regulatory record for Stalif C
Listed by Centinel Spine, LLC, United States
FDA product code OVE
Device type Intervertebral Fusion Device With Integrated Fixation, Cervical
Device class Class 2
Regulation 21 CFR 888.3080
Establishment Specification developer, Complaint-file establishment, Manufacturer
510(k) K120819
Record published 2017-03-13
Record revised 2026-05-21 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Stalif C
Catalogue number Size Status
C169579-3T In distribution
C165538-2T In distribution
C165539-3T In distribution
C148571-3D In distribution
C145541-3D-I In distribution
C141210-3D In distribution
RAB1740 In distribution
ABS1340 In distribution
C149581-3D In distribution
C146551-3D In distribution
RAB1340 In distribution
C146551-3D-I In distribution
C125541-3D In distribution
C147561-3D-I In distribution
C169579-3D In distribution
C147561-3D In distribution
C161189-3T In distribution
C126551-3T In distribution
C166549-3T In distribution
C129581-3D In distribution
ABS1540 In distribution
ABS1440 In distribution
C125541-3T In distribution
C127561-3D In distribution
C121191-3D In distribution
RAB1540 In distribution
C168569-3D In distribution
C148571-3D-I In distribution
C161299-3T In distribution
C149581-3D-I In distribution
C121191-3T In distribution
C121210-3D In distribution
C147561-3T In distribution
C129581-3T In distribution
RAB1640 In distribution
C145541-3D In distribution
C149581-3T In distribution
C128571-3D In distribution
C127561-3T In distribution
C141191-3D In distribution
C141210-3T In distribution
C145541-3T In distribution
ABS1740 In distribution
ABS1640 In distribution
C161189-3D In distribution
C146551-3T In distribution
C121210-3T In distribution
C168569-3T In distribution
C166549-3D In distribution
C148571-3T In distribution
C165539-3D In distribution
C167559-3T In distribution
C161299-3D In distribution
C128571-3T In distribution
C126551-3D In distribution
C141191-3T In distribution
C167559-3D In distribution
RAB1440 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
IdentiTi Alphatec Spine, Inc. 630
Dolomite Astura Medical 607
CoRoent Nuvasive, Inc. 580
Aeon-C Diomedical Co., Ltd. 508
Tomcat™ Cervical Spinal System Choice Spine, LP 468
Shoreline ACS Seaspine Orthopedics Corporation 428
Zavation Zavation 423
Alta™ Stand-Alone Interbody Fusion System Biomet Spine 404
Unison™-C Anterior Cervical Fixation System Pioneer Surgical Technology, Inc. 334
Chesapeake® Stabilization System VB Spine LLC 272
UniSpace® Stand-Alone C Cage CG MedTech Co., Ltd. 260
Solitaire-C Cervical Spacer Biomet Spine 256

Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K150053 2015-06-24
K142079 2014-10-24
K133200 2014-05-08
K120819 2012-08-31

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