Endeavor™ Stand-Alone Cervical

SA Cervical, 18W x 15D x 10H x 12°, HA & ß-TCP PEEK, Ti 6Al 4V (ELI), Ta

Registry build 21.09.26
5manufacturers in China registered for this device type
50catalogue numbers in this listing

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 Endeavor™ Stand-Alone Cervical
Listed by Inno-Health Technology Co., Ltd., Taiwan
FDA product code OVE
Device type Intervertebral Fusion Device With Integrated Fixation, Cervical
Device class Class 2
Regulation 21 CFR 888.3080
Establishment Contract manufacturer, Contract steriliser, Manufacturer
510(k) K250076
Record published 2026-05-31

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Radiation Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Packaging Carton
Sizes Width 14 to 18 mm; depth 12 to 15 mm; height 6 to 12 mm; outer diameter 3.5 to 4 mm; length 10 to 18 mm

Catalogue Numbers

Catalogue numbers for Endeavor™ Stand-Alone Cervical
Catalogue number Size Status
51-180607 Width 18 mm In distribution
51-160812 Width 16 mm In distribution
51-180707 Width 18 mm In distribution
51-160712 Width 16 mm In distribution
51-181107 Width 18 mm In distribution
51-180907 Width 18 mm In distribution
51-140707 Width 14 mm In distribution
51-181012 Width 18 mm In distribution
51-140712 Width 14 mm In distribution
51-4012 Outer Diameter 4.0 mm In distribution
51-3516 Outer Diameter 3.5 mm In distribution
51-161112 Width 16 mm In distribution
51-181007 Width 18 mm In distribution
51-3510 Outer Diameter 3.5 mm In distribution
51-180807 Width 18 mm In distribution
51-160707 Width 16 mm In distribution
51-140607 Width 14 mm In distribution
51-181112 Width 18 mm In distribution
51-3514 Outer Diameter 3.5 mm In distribution
51-141112 Width 14 mm In distribution
51-141007 Width 14 mm In distribution
51-180712 Width 18 mm In distribution
51-160912 Width 16 mm In distribution
51-4014 Outer Diameter 4.0 mm In distribution
51-4010 Outer Diameter 4.0 mm In distribution
51-140912 Width 14 mm In distribution
51-160807 Width 16 mm In distribution
51-161007 Width 16 mm In distribution
51-4016 Outer Diameter 4.0 mm In distribution
51-140807 Width 14 mm In distribution
51-01 In distribution
51-161212 Width 16 mm In distribution
51-180912 Width 18 mm In distribution
51-3512 Outer Diameter 3.5 mm In distribution
51-181207 Width 18 mm In distribution
51-161107 Width 16 mm In distribution
51-141012 Width 14 mm In distribution
51-160907 Width 16 mm In distribution
51-181212 Width 18 mm In distribution
51-180812 Width 18 mm In distribution
51-161012 Width 16 mm In distribution
51-140907 Width 14 mm In distribution
51-3518 Outer Diameter 3.5 mm In distribution
51-161207 Width 16 mm In distribution
51-140812 Width 14 mm In distribution
51-141107 Width 14 mm In distribution
51-4018 Outer Diameter 4.0 mm In distribution
51-141207 Width 14 mm In distribution
51-160607 Width 16 mm In distribution
51-141212 Width 14 mm 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

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