Orthopedic › ProstheticIntervertebral Fusion Device With Bone Graft, Cervical

HiJAK™ Cervical

Short Implant Inserter with Depth Stop, HiJAK™ Cervical

Registry build 21.09.26
7manufacturers in China registered for this device type
144catalogue numbers in this listing
3510(k) clearances naming this product code

Who Else Makes It

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

Chinese manufacturers registered for FDA product code ODP
Manufacturer City Province Registered as Device types
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Zhisu Health Tech Jiaxing Co., Ltd. Tongxiang Zhejiang Contract manufacturer 4
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Zhejiang Decans Medical Devices Co., Ltd. Jiaxing Zhejiang Manufacturer 10
Shanghai Sanyou Medical Co., Ltd. Shanghai Shanghai Manufacturer 6

Record

Regulatory record for HiJAK™ Cervical
Listed by Atlas Spine Inc., United States
FDA product code ODP
Device type Intervertebral Fusion Device With Bone Graft, Cervical
Device class Class 2
Regulation 21 CFR 888.3080
Establishment Manufacturer
510(k) K180675
Record published 2019-09-30
Record revised 2023-06-14 (version 4)

Specifications

Specifications
MRI safety MR Conditional
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Sizes Height 7 to 14 mm

Catalogue Numbers

Catalogue numbers for HiJAK™ Cervical
Catalogue number Size Status
1119-10-0013 Height 13 mm In distribution
2019-01-0013 In distribution
2019-01-0005 In distribution
2019-09-0012 Height 12 mm In distribution
2019-01-0000 In distribution
2019-06-0011 Height 11 mm In distribution
2019-03-0010 Height 10 mm In distribution
2019-01-0002 In distribution
1119-08-0010 Height 10 mm In distribution
1119-07-0012 Height 12 mm In distribution
1119-03-0008 Height 8 mm In distribution
1119-09-0010 In distribution
2019-02-0009 Height 9 mm In distribution
1119-07-0010 Height 10 mm In distribution
1119-09-0013 In distribution
2019-08-0010 Height 10 mm In distribution
1119-04-0014 Height 14 mm In distribution
2019-08-0009 Height 9 mm In distribution
2019-03-0008 Height 8 mm In distribution
2019-08-0008 Height 8 mm In distribution
1119-04-0012 Height 12 mm In distribution
1119-04-0008 Height 8 mm In distribution
1119-01-0008 Height 8 mm In distribution
1119-07-0011 Height 11 mm In distribution
1119-08-0013 Height 13 mm In distribution
2019-01-0017 In distribution
1119-03-0009 Height 9 mm In distribution
1119-03-0007 Height 7 mm In distribution
2019-02-0008 Height 8 mm In distribution
2019-03-0011 Height 11 mm In distribution
1119-08-0008 Height 8 mm In distribution
1119-04-0013 Height 13 mm In distribution
1119-09-0012 Height 12 mm In distribution
1119-10-0010 Height 10 mm In distribution
1119-02-0008 Height 8 mm In distribution
2019-05-0011 In distribution
1119-07-0014 In distribution
1119-01-0007 Height 7 mm In distribution
2019-08-0011 Height 11 mm In distribution
2019-01-0004 In distribution
1119-02-0011 Height 11 mm In distribution
1119-02-0014 Height 14 mm In distribution
2019-01-0016 In distribution
1119-07-0009 Height 9 mm In distribution
2019-09-0007 In distribution
1119-02-0007 Height 7 mm In distribution
2019-01-0011 In distribution
2019-07-0011 Height 11 mm In distribution
1119-09-0008 Height 8 mm In distribution
2019-03-0009 Height 9 mm In distribution
1119-10-0014 Height 14 mm In distribution
2019-01-0001 In distribution
2019-07-0008 Height 8 mm In distribution
1119-02-0012 Height 12 mm In distribution
2019-09-0014 Height 14 mm In distribution
1119-02-0010 Height 10 mm In distribution
2019-09-0013 Height 13 mm In distribution
2019-07-0014 Height 14 mm In distribution
1119-07-0013 In distribution
2019-03-0014 Height 14 mm In distribution
2019-05-0012 Height 12 mm In distribution
2019-07-0013 Height 13 mm In distribution
1119-10-0009 Height 9 mm In distribution
2019-07-0010 Height 10 mm In distribution
1119-07-0008 Height 8 mm In distribution
1119-08-0009 Height 9 mm In distribution
2019-04-0009 Height 9 mm In distribution
2019-01-0015 In distribution
2019-06-0014 Height 14 mm In distribution
1119-03-0010 Height 10 mm In distribution
2019-06-0010 Height 10 mm In distribution
2019-05-0008 Height 8 mm In distribution
2019-01-0009 In distribution
1119-01-0013 Height 13 mm In distribution
2019-04-0008 Height 8 mm In distribution
1119-03-0014 Height 14 mm In distribution
2019-06-0009 Height 9 mm In distribution
1119-03-0011 Height 11 mm In distribution
2019-02-0011 Height 11 mm In distribution
2019-06-0008 Height 8 mm In distribution
1119-04-0007 Height 7 mm In distribution
1119-04-0010 Height 10 mm In distribution
1119-03-0013 Height 13 mm In distribution
2019-01-0014 In distribution
1119-08-0012 Height 12 mm In distribution
2019-02-0014 In distribution
1119-01-0012 Height 12 mm In distribution
1119-06-0007 Height 7 mm In distribution
2019-01-0012 In distribution
2019-01-0010 In distribution
1119-09-0009 Height 9 mm In distribution
2019-01-0007 In distribution
2019-09-0011 Height 11 mm In distribution
2019-09-0010 Height 10 mm In distribution
2019-04-0010 Height 10 mm In distribution
2019-05-0010 Height 10 mm In distribution
1119-01-0009 Height 9 mm In distribution
2019-09-0009 Height 9 mm In distribution
2019-05-0009 Height 9 mm In distribution
2019-08-0007 Height 7 mm In distribution
2019-01-0019 In distribution
2019-05-0007 Height 7 mm In distribution
1119-01-0014 Height 14 mm In distribution
2019-07-0009 Height 9 mm In distribution
2019-05-0013 Height 13 mm In distribution
1119-10-0011 Height 11 mm In distribution
1119-08-0011 Height 11 mm In distribution
2019-01-0020 In distribution
2019-05-0014 Height 14 mm In distribution
2019-02-0013 Height 13 mm In distribution
2019-06-0013 Height 13 mm In distribution
1119-09-0011 Height 11 mm In distribution
2019-04-0014 Height 14 mm In distribution
2019-03-0013 Height 13 mm In distribution
2019-08-0014 Height 14 mm In distribution
2019-08-0013 Height 13 mm In distribution
2019-02-0010 Height 10 mm In distribution
2019-04-0007 Height 7 mm In distribution
2019-01-0018 In distribution
1119-10-0012 Height 12 mm In distribution
1119-01-0010 Height 10 mm In distribution
2019-03-0012 Height 12 mm In distribution
1119-02-0013 Height 13 mm In distribution
2019-04-0011 Height 11 mm In distribution
1119-05-0007 Height 7 mm In distribution
2019-04-0012 Height 12 mm In distribution
1119-02-0009 In distribution
HiJAK™ Cervical Height 9 mm In distribution
2019-09-0008 In distribution
2019-07-0012 Height 12 mm In distribution
1119-03-0012 Height 12 mm In distribution
1119-09-0014 Height 14 mm In distribution
1119-01-0011 In distribution
2019-04-0013 Height 13 mm In distribution
1119-04-0011 Height 11 mm In distribution
1119-10-0008 Height 8 mm In distribution
2019-01-0008 In distribution
1119-08-0014 Height 14 mm In distribution
2019-01-0003 In distribution
2019-08-0012 In distribution
2019-02-0012 Height 12 mm In distribution
2019-03-0007 Height 7 mm In distribution
2019-06-0012 Height 12 mm In distribution
2019-01-0006 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Latitude-C AM™ Cervical Interbody Fusion System Degen Medical 1,529
IdentiTi Alphatec Spine, Inc. 1,390
Zavation Zavation 1,357
IVA Cage Ti Diomedical Co., Ltd. 1,202
Latitude-C Cervical Interbody Spacer System Degen Medical 1,185
Peridot Anterior Cervical Intervertebral Body Fusion System Gbs Commonwealth Co., Ltd. 1,056
Aleutian® Interbody Systems VB Spine LLC 1,017
Valeo Spacer System Sintx Technologies Inc. 918
Cascadia™ Interbody System VB Spine LLC 823
CoRoent Nuvasive, Inc. 815
Tyber Medical Tyber Medical 740
Matisse Anterior Cervical Interbody Fusion Cage System CTL Medical Corporation 577

Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K202302 2020-10-30
K180675 2018-06-13
K081880 2008-10-02

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