Orthopedic › ProstheticIntervertebral Fusion Device With Integrated Fixation, Cervical

Tomcat™ Cervical Spinal System

TOMCAT,STERILE,HYBRID,HA,16X16X7,11

Registry build 21.09.26
5manufacturers in China registered for this device type
468catalogue 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 Tomcat™ Cervical Spinal System
Listed by Choice Spine, LP
FDA product code OVE
Device type Intervertebral Fusion Device With Integrated Fixation, Cervical
Device class Class 2
Regulation 21 CFR 888.3080
510(k) K152515
Record published 2016-01-25
Record revised 2020-02-24 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, serial number
Sizes Height 6 to 12 mm; depth 12 to 18 mm; width 14 to 16 mm; outer diameter 3.5 to 4 mm; length 10 to 18 mm
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Tomcat™ Cervical Spinal System
Catalogue number Size Status
RH30-1618808 Height 8 mm In distribution
RH20-1614407 Height 7 mm In distribution
S-RH30-1616706 Depth 16 mm In distribution
S-RH20-1616807 Width 16 mm In distribution
RH20-1614408 Width 16 mm In distribution
RH20-1618806 Height 6 mm In distribution
S-RH20-1412708 Width 14 mm In distribution
S-RH20-1614507 Width 16 mm In distribution
RH20-1412012 Width 14 mm In distribution
S-RH20-1614408 Depth 14 mm In distribution
RH20-1412007 Depth 12 mm In distribution
S-RH20-1412806 Width 14 mm In distribution
RH30-1618412 Depth 18 mm In distribution
RH30-1618406 Depth 18 mm In distribution
S-RH30-1616407 Width 16 mm In distribution
RH20-1616012 Width 16 mm In distribution
S-RH30-1616711 Depth 16 mm In distribution
S-RH20-1618808 Depth 18 mm In distribution
S-RH20-1412012 Depth 12 mm In distribution
S-RH30-1614010 Width 16 mm In distribution
S-RH20-1618010 Width 16 mm In distribution
S-RH30-1412010 Height 10 mm In distribution
S-RH20-1618011 Width 16 mm In distribution
S-RH30-1614706 Width 16 mm In distribution
S-RH30-1618712 Height 12 mm In distribution
S-RH30-1618707 Width 16 mm In distribution
RH20-1614806 Width 16 mm In distribution
S-RH30-1412012 Depth 12 mm In distribution
RH20-1618811 Height 11 mm In distribution
RT10-D3514 Outer Diameter 3.5 mm In distribution
RH20-1618809 Height 9 mm In distribution
S-RH30-1614709 Depth 14 mm In distribution
S-RH30-1618812 Width 16 mm In distribution
S-RH30-1616811 Depth 16 mm In distribution
RH30-1412007 Height 7 mm In distribution
S-RH20-1618709 Width 16 mm In distribution
RT10-D3518 Length 18 mm In distribution
S-RH30-1412512 Width 14 mm In distribution
S-RH30-1618407 Height 7 mm In distribution
S-RH20-1412808 Height 8 mm In distribution
RH20-1614008 Height 8 mm In distribution
S-RH30-1412808 Height 8 mm In distribution
S-RH30-1618708 Height 8 mm In distribution
S-RH20-1614511 Height 11 mm In distribution
RH30-1618409 Depth 18 mm In distribution
S-RH30-1616010 Height 10 mm In distribution
S-RH20-1412508 Width 14 mm In distribution
S-RH30-1618506 Width 16 mm In distribution
RH30-1412412 Height 12 mm In distribution
S-RH30-1614512 Width 16 mm In distribution
S-RH20-1614412 Width 16 mm In distribution
S-RH20-1618807 Height 7 mm In distribution
S-RH20-1412007 Height 7 mm In distribution
RH30-1616412 Depth 16 mm In distribution
S-RH30-1412709 Depth 12 mm In distribution
S-RH30-1412009 Height 9 mm In distribution
S-RH20-1412010 Height 10 mm In distribution
RH20-1614808 Height 8 mm In distribution
S-RH30-1412807 Height 7 mm In distribution
S-RH20-1614008 Depth 14 mm In distribution
S-RH30-1412508 Width 14 mm In distribution
S-RH20-1616512 Width 16 mm In distribution
RH30-1614412 Height 12 mm In distribution
RH20-1616811 Width 16 mm In distribution
RH30-1618407 Depth 18 mm In distribution
S-RH20-1616406 Height 6 mm In distribution
S-RH30-1618509 Depth 18 mm In distribution
S-RH30-1614806 Width 16 mm In distribution
S-RH30-1614811 Width 16 mm In distribution
RH30-1412012 Width 14 mm In distribution
RH30-1412406 Width 14 mm In distribution
S-RH20-1614506 Width 16 mm In distribution
S-RH20-1614809 Depth 14 mm In distribution
RH30-1618411 Depth 18 mm In distribution
S-RH30-1412412 Width 14 mm In distribution
S-RH30-1616411 Height 11 mm In distribution
RH20-1614007 Width 16 mm In distribution
S-RH20-1614712 Height 12 mm In distribution
S-RH30-1616808 Width 16 mm In distribution
RH30-1412409 Depth 12 mm In distribution
S-RH30-1618806 Height 6 mm In distribution
RT10-T4010 Outer Diameter 4 mm In distribution
S-RH30-1412409 Width 14 mm In distribution
RH20-1614010 Width 16 mm In distribution
S-RH30-1618409 Width 16 mm In distribution
RT10-T3510 Length 10 mm In distribution
S-RH20-1616411 Height 11 mm In distribution
S-RH30-1412407 Depth 12 mm In distribution
RH30-1616409 Height 9 mm In distribution
RH30-1614009 Height 9 mm In distribution
S-RH30-1614408 Depth 14 mm In distribution
S-RH20-1616410 Depth 16 mm In distribution
RH30-1614408 Depth 14 mm In distribution
RH20-1616810 Height 10 mm In distribution
S-RH30-1412712 Width 14 mm In distribution
RH20-1618411 Depth 18 mm In distribution
S-RH30-1618008 Height 8 mm In distribution
S-RH20-1616011 Width 16 mm In distribution
S-RH30-1618508 Depth 18 mm In distribution
RT10-D3510 Outer Diameter 3.5 mm In distribution
RH30-1616010 Depth 16 mm In distribution
RH20-1614411 Depth 14 mm In distribution
S-RH20-1412706 Depth 12 mm In distribution
S-RH20-1618510 Height 10 mm In distribution
S-RH30-1412408 Depth 12 mm In distribution
RH30-1618009 Width 16 mm In distribution
S-RH20-1412410 Depth 12 mm In distribution
RH20-1412008 Depth 12 mm In distribution
S-RH30-1616809 Height 9 mm In distribution
S-RH20-1614707 Depth 14 mm In distribution
S-RH30-1614711 Width 16 mm In distribution
RH30-1618807 Depth 18 mm In distribution
S-RH30-1412810 Depth 12 mm In distribution
S-RH30-1614407 Height 7 mm In distribution
RH30-1616006 Depth 16 mm In distribution
S-RH20-1614711 Width 16 mm In distribution
RT10-T4018 Length 18 mm In distribution
S-RH30-1616511 Height 11 mm In distribution
S-RH30-1616410 Width 16 mm In distribution
RH30-1618811 Width 16 mm In distribution
S-RH20-1614709 Height 9 mm In distribution
RH20-1618408 Depth 18 mm In distribution
S-RH30-1616806 Height 6 mm In distribution
RH30-1616408 Depth 16 mm In distribution
RT10-T3516 Length 16 mm In distribution
S-RH20-1618406 Width 16 mm In distribution
S-RH30-1412006 Depth 12 mm In distribution
S-RH20-1616007 Height 7 mm In distribution
S-RH30-1614810 Depth 14 mm In distribution
S-RH20-1618012 Width 16 mm In distribution
RH30-1616810 Height 10 mm In distribution
S-RH20-1616812 Depth 16 mm In distribution
S-RH30-1614808 Depth 14 mm In distribution
RT10-D3512 Length 12 mm In distribution
RT10-D4018 Length 18 mm In distribution
S-RH20-1614012 Height 12 mm In distribution
RH20-1614810 Depth 14 mm In distribution
S-RH20-1614812 Depth 14 mm In distribution
S-RH20-1616711 Width 16 mm In distribution
S-RH20-1614811 Height 11 mm In distribution
RH30-1412009 Depth 12 mm In distribution
RH20-1412410 Width 14 mm In distribution
RH30-1618007 Height 7 mm In distribution
RH20-1412409 Width 14 mm In distribution
S-RH30-1616707 Width 16 mm In distribution
S-RH20-1412711 Depth 12 mm In distribution
S-RH30-1412511 Depth 12 mm In distribution
S-RH30-1618012 Width 16 mm In distribution
S-RH20-1412506 Height 6 mm In distribution
RH20-1618406 Height 6 mm In distribution
RH20-1614812 Width 16 mm In distribution
S-RH30-1618010 Width 16 mm In distribution
RH30-1614407 Depth 14 mm In distribution
S-RH30-1614406 Height 6 mm In distribution
S-RH20-1618711 Width 16 mm In distribution
RH30-1616809 Width 16 mm In distribution
S-RH30-1412812 Depth 12 mm In distribution
S-RH30-1412406 Depth 12 mm In distribution
S-RH20-1412811 Height 11 mm In distribution
RH20-1412412 Depth 12 mm In distribution
RH30-1412810 Width 14 mm In distribution
RH20-1412411 Width 14 mm In distribution
RH20-1412006 Depth 12 mm In distribution
S-RH30-1616006 Depth 16 mm In distribution
S-RH30-1618011 Width 16 mm In distribution
S-RH20-1614806 Height 6 mm In distribution
RH30-1616411 Depth 16 mm In distribution
S-RH20-1412006 Height 6 mm In distribution
RH30-1412008 Depth 12 mm In distribution
RH30-1616807 Depth 16 mm In distribution
S-RH30-1616012 Depth 16 mm In distribution
S-RH20-1616509 Depth 16 mm In distribution
RH20-1616411 Height 11 mm In distribution
S-RH30-1412007 Depth 12 mm In distribution
RH20-1412811 Depth 12 mm In distribution
S-RH30-1616409 Width 16 mm In distribution
S-RH30-1618411 Depth 18 mm In distribution
RH30-1618809 Width 16 mm In distribution
RH20-1618812 Height 12 mm In distribution
S-RH20-1616709 Height 9 mm In distribution
RH30-1616806 Height 6 mm In distribution
S-RH20-1618009 Depth 18 mm In distribution
S-RH20-1616506 Width 16 mm In distribution
RH30-1412006 Height 6 mm In distribution
RH20-1618006 Height 6 mm In distribution
S-RH20-1614009 Height 9 mm In distribution
S-RH20-1616809 Depth 16 mm In distribution
RH30-1412808 Height 8 mm In distribution
S-RH30-1618808 Depth 18 mm In distribution
RH20-1616808 Depth 16 mm In distribution
S-RH20-1616412 Depth 16 mm In distribution
RH30-1614010 Width 16 mm In distribution
S-RH20-1614512 Depth 14 mm In distribution
S-RH20-1616808 Depth 16 mm In distribution
S-RH20-1616511 Height 11 mm In distribution
RH20-1412406 Width 14 mm In distribution
S-RH20-1412009 Width 14 mm In distribution
S-RH30-1616712 Height 12 mm In distribution
RH20-1616807 Height 7 mm In distribution
S-RH30-1616512 Height 12 mm In distribution
RH30-1616808 Height 8 mm In distribution
RH20-1614412 Height 12 mm In distribution
RH20-1412407 Depth 12 mm In distribution
S-RH30-1412011 Depth 12 mm In distribution
RT10-D4016 Length 16 mm In distribution
S-RH30-1412410 Height 10 mm In distribution
RT10-D4014 Length 14 mm In distribution
S-RH20-1616010 Width 16 mm In distribution
S-RH30-1614809 Depth 14 mm In distribution
S-RH20-1616508 Depth 16 mm In distribution
RH30-1618810 Width 16 mm In distribution
RH30-1614012 Height 12 mm In distribution
S-RH20-1412812 Height 12 mm In distribution
RH20-1616006 Width 16 mm In distribution
RH30-1616011 Depth 16 mm In distribution
S-RH30-1616709 Depth 16 mm In distribution
S-RH30-1614008 Depth 14 mm In distribution
S-RH20-1616708 Height 8 mm In distribution
S-RH30-1614710 Height 10 mm In distribution
RH30-1412410 Width 14 mm In distribution
RH30-1614006 Height 6 mm In distribution
S-RH30-1614507 Depth 14 mm In distribution
S-RH20-1618407 Depth 18 mm In distribution
RT10-D4012 Outer Diameter 4 mm In distribution
RH20-1412011 Width 14 mm In distribution
S-RH20-1616707 Width 16 mm In distribution
S-RH30-1618410 Width 16 mm In distribution
S-RH20-1616006 Width 16 mm In distribution
RT10-T4016 Length 16 mm In distribution
RH30-1614011 Height 11 mm In distribution
S-RH20-1412509 Height 9 mm In distribution
S-RH30-1618809 Width 16 mm In distribution
S-RH30-1616008 Depth 16 mm In distribution
RH30-1616812 Width 16 mm In distribution
RH30-1614812 Width 16 mm In distribution
RH20-1618409 Depth 18 mm In distribution
S-RH20-1412512 Width 14 mm In distribution
S-RH30-1614708 Width 16 mm In distribution
S-RH30-1618510 Width 16 mm In distribution
S-RH20-1614006 Width 16 mm In distribution
S-RH20-1618710 Depth 18 mm In distribution
RH30-1618812 Height 12 mm In distribution
S-RH30-1614006 Height 6 mm In distribution
RH20-1618009 Depth 18 mm In distribution
S-RH30-1618007 Width 16 mm In distribution
S-RH20-1614710 Height 10 mm In distribution
S-RH30-1616408 Width 16 mm In distribution
S-RH30-1412008 Height 8 mm In distribution
RH20-1618007 Width 16 mm In distribution
RH30-1618012 Depth 18 mm In distribution

Showing 250 of 300 catalogue numbers.

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
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
A-Cift Spinefrontier, Inc. 254

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