Orthopedic › ProstheticIntervertebral Fusion Device With Bone Graft, Cervical

IdentiTi

Atec Porous TI, Cervical, 6 Height, 16 Width, 14 Depth, 7.5°

Registry build 21.09.26
7manufacturers in China registered for this device type
1,390catalogue numbers in this listing
4510(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 IdentiTi
Listed by Alphatec 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 Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k) K233640
Record published 2024-06-02
Record revised 2025-07-14 (version 3)

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, manufacturing date
Sizes Width 14 to 38 mm; height 4 to 16 mm; angle 5 to 30 °; depth 12 to 70 mm; length 12 to 28 mm
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for IdentiTi
Catalogue number Size Status
127-10-14181512 Depth 15 mm In distribution
127-11-08181615 Angle 15 ° In distribution
127-10-10141215 Height 10 mm In distribution
127-20-08201612 Angle 12 ° In distribution
127-21-09201615 Width 20 mm In distribution
127-20-10181605 Height 10 mm In distribution
334-10181510-S Width 18 mm In distribution
334-10181505-S Angle 5 ° In distribution
127-21-13201615 Width 20 mm In distribution
334-08181505-S Width 18 mm In distribution
127-10-12161410 Height 12 mm In distribution
127-20-07161405 Height 7 mm In distribution
126-07161415-S Angle 15 ° In distribution
334-10141205-S Height 10 mm In distribution
255-14-11186015 Depth 60 mm In distribution
127-10-12181612 Length 16 mm In distribution
127-10-06161412 Length 14 mm In distribution
127-11-13181615 Width 18 mm In distribution
127-11-04181600 Width 18 mm In distribution
129-10382820-S Length 28 mm In distribution
127-10-12161407 Width 16 mm In distribution
127-21-10201600 Depth 16 mm In distribution
126-07161410-S Angle 10 ° In distribution
127-100 In distribution
127-20-07141212 Height 7 mm In distribution
CI-10275-06141205 Height 6 mm In distribution
127-21-10161400 Height 10 mm In distribution
127-10-05161407 Height 5 mm In distribution
127-11-06141210 Height 6 mm In distribution
255-30-08266010 Depth 60 mm In distribution
127-11-11201607 Height 11 mm In distribution
127-11-12201610 Angle 10 ° In distribution
127-21-07201607 Width 20 mm In distribution
127-10-13181615 Height 13 mm In distribution
127-21-12201612 Height 12 mm In distribution
127-21-07141210 Depth 12 mm In distribution
255-14-09186030 Angle 30 ° In distribution
127-10-13161407 Angle 7 ° In distribution
255-30-06266015 Width 26 mm In distribution
127-10-08161412 Height 8 mm In distribution
127-10-11141215 Height 11 mm In distribution
127-10-05141207 Height 5 mm In distribution
255-10-06227020 Depth 70 mm In distribution
127-11-05141207 Angle 7 ° In distribution
115-002 In distribution
127-11-10201610 Height 10 mm In distribution
127-10-09181515 Angle 15 ° In distribution
127-20-12201615 Angle 15 ° In distribution
127-10-11181512 Height 11 mm In distribution
127-11-08201605 Depth 16 mm In distribution
127-10-09161405 Width 16 mm In distribution
127-21-12141215 Angle 15 ° In distribution
127-10-09181512 Width 18 mm In distribution
127-10-05181600 Length 16 mm In distribution
126-08161415-S Height 8 mm In distribution
127-11-11181610 Width 18 mm In distribution
127-10-14181615 Length 16 mm In distribution
127-10-10181512 Depth 15 mm In distribution
334-07181510-S Height 7 mm In distribution
334-12141215-S Angle 15 ° In distribution
127-10-08181515 Width 18 mm In distribution
126-07141207-S Angle 7 ° In distribution
255-10-08267005 Angle 5 ° In distribution
127-20-08161407 Angle 7 ° In distribution
334-13141212-S Angle 12 ° In distribution
127-20-09141210 Height 9 mm In distribution
127-11-08141205 Depth 12 mm In distribution
127-11-14141212 Angle 12 ° In distribution
127-11-07181605 Angle 5 ° In distribution
127-10-10181507 Width 18 mm In distribution
127-10-11141207 Width 14 mm In distribution
127-21-12161412 Depth 14 mm In distribution
127-10-11181610 Height 11 mm In distribution
127-10-06181512 Angle 12 ° In distribution
127-10-09201610 Angle 10 ° In distribution
127-10-08181507 Height 8 mm In distribution
334-13161412-S Height 13 mm In distribution
127-21-12181615 Angle 15 ° In distribution
127-11-11161412 Width 16 mm In distribution
127-21-10141210 Angle 10 ° In distribution
255-30-13266015 Depth 60 mm In distribution
127-20-07201600 Height 7 mm In distribution
127-10-06161405 Angle 5 ° In distribution
334-09161405-S Depth 14 mm In distribution
127-20-10181607 Length 16 mm In distribution
127-11-10181610 Depth 16 mm In distribution
127-11-08201610 Depth 16 mm In distribution
127-11-12181607 Width 18 mm In distribution
CI-10528-09181607 Angle 7 ° In distribution
127-10-11181612 Height 11 mm In distribution
255-14-04226030 Height 4 mm In distribution
CI-10528-06161407 Width 16 mm In distribution
127-10-10181605 Length 16 mm In distribution
127-20-06141210 Height 6 mm In distribution
CI-10528-05141207 Depth 12 mm In distribution
127-21-08161407 Depth 14 mm In distribution
126-10141207-S Angle 7 ° In distribution
127-21-06141215 Width 14 mm In distribution
127-10-08201607 Width 20 mm In distribution
127-20-11161400 Length 14 mm In distribution
127-20-09201615 Height 9 mm In distribution
334-11161410-S Width 16 mm In distribution
127-10-13141212 Angle 12 ° In distribution
334-09141210-S Depth 12 mm In distribution
127-10-10141205 Height 10 mm In distribution
127-10-13201615 Height 13 mm In distribution
126-08161410-S Width 16 mm In distribution
126-12141207-S Width 14 mm In distribution
126-07201610-S Width 20 mm In distribution
255-10-14227000 Width 22 mm In distribution
127-10-11201607 Width 20 mm In distribution
127-20-14181610 Height 14 mm In distribution
126-10181607-S Angle 7 ° In distribution
127-21-13201605 Angle 5 ° In distribution
127-10-08141215 Width 14 mm In distribution
334-07181515-S Height 7 mm In distribution
127-21-11141200 Width 14 mm In distribution
CI-10528-12141207 Depth 12 mm In distribution
255-12-09266025 Width 26 mm In distribution
255-14-05186005 Height 5 mm In distribution
127-21-08201600 Width 20 mm In distribution
126-07201607-S Height 7 mm In distribution
127-11-13161412 Width 16 mm In distribution
126-11141207-S Angle 7 ° In distribution
127-20-08201605 Width 20 mm In distribution
127-20-13201615 Length 16 mm In distribution
255-10-10187005 Height 10 mm In distribution
126-09181610-S Depth 16 mm In distribution
127-11-05161405 Width 16 mm In distribution
127-20-07181610 Width 18 mm In distribution
127-21-08161415 Height 8 mm In distribution
127-10-13161410 Height 13 mm In distribution
334-07181505-S Depth 15 mm In distribution
127-11-14181615 Angle 15 ° In distribution
127-21-08201615 Angle 15 ° In distribution
127-10-10141210 Length 12 mm In distribution
127-10-11161405 Height 11 mm In distribution
127-20-06141200 Width 14 mm In distribution
255-14-07266010 Height 7 mm In distribution
127-11-05201600 Height 5 mm In distribution
127-10-08161407 Width 16 mm In distribution
127-10-12141205 Width 14 mm In distribution
CI-10275-09141205 Depth 12 mm In distribution
127-10-13161412 Length 14 mm In distribution
127-21-12141210 Depth 12 mm In distribution
255-10-14165510 Depth 55 mm In distribution
127-20-07181607 Height 7 mm In distribution
127-11-13201605 Angle 5 ° In distribution
127-10-13181605 Angle 5 ° In distribution
255-10-08187000 Width 18 mm In distribution
127-20-05161400 Width 16 mm In distribution
255-14-04226010 Depth 60 mm In distribution
334-06161412-S Height 6 mm In distribution
127-20-11141210 Angle 10 ° In distribution
127-10-08181607 Height 8 mm In distribution
127-10-07161407 Height 7 mm In distribution
126-11181615-S Angle 15 ° In distribution
127-21-12201610 Height 12 mm In distribution
127-11-08161415 Depth 14 mm In distribution
127-21-11161415 Width 16 mm In distribution
255-12-06266025 Angle 25 ° In distribution
127-10-08181610 Width 18 mm In distribution
255-10-10227025 Depth 70 mm In distribution
334-12161407-S Angle 7 ° In distribution
109-06161407-S Width 16 mm In distribution
127-10-14161410 Length 14 mm In distribution
127-21-07141207 Height 7 mm In distribution
127-11-09181610 Depth 16 mm In distribution
127-10-06201610 Length 16 mm In distribution
127-10-12181510 Height 12 mm In distribution
127-21-08181600 Width 18 mm In distribution
126-06141215-S Length 12 mm In distribution
127-10-07201610 Width 20 mm In distribution
255-10-04227025 Width 22 mm In distribution
126-08141205-S Width 14 mm In distribution
127-21-11141212 Angle 12 ° In distribution
255-10-13267005 Height 13 mm In distribution
334-08181512-S Width 18 mm In distribution
127-21-09141205 Depth 12 mm In distribution
CI-10528-09141207 Angle 7 ° In distribution
127-21-10161412 Height 10 mm In distribution
127-20-06201610 Angle 10 ° In distribution
334-11141215-S Depth 12 mm In distribution
127-11-12201600 Width 20 mm In distribution
127-10-10181510 Height 10 mm In distribution
255-12-14186005 Depth 60 mm In distribution
127-10-10201605 Width 20 mm In distribution
127-20-05141205 Height 5 mm In distribution
127-11-11181600 Height 11 mm In distribution
127-20-08161412 Length 14 mm In distribution
127-11-12201605 Height 12 mm In distribution
127-11-06181610 Depth 16 mm In distribution
127-11-07201612 Depth 16 mm In distribution
127-10-06181600 Height 6 mm In distribution
127-20-09141212 Height 9 mm In distribution
127-20-07201610 Height 7 mm In distribution
255-30-14186030 Height 14 mm In distribution
127-11-08141207 Depth 12 mm In distribution
127-20-07201612 Width 20 mm In distribution
127-21-12161405 Depth 14 mm In distribution
127-10-14161415 Width 16 mm In distribution
127-11-07181607 Angle 7 ° In distribution
255-14-04186025 Depth 60 mm In distribution
127-20-10161415 Angle 15 ° In distribution
127-10-11161410 Width 16 mm In distribution
127-20-08141205 Height 8 mm In distribution
255-30-04226030 Angle 30 ° In distribution
127-21-14181610 Height 14 mm In distribution
127-20-11161407 Length 14 mm In distribution
127-10-11161412 Height 11 mm In distribution
334-06141210-S Depth 12 mm In distribution
255-14-04266005 Width 26 mm In distribution
255-12-08226010 Width 22 mm In distribution
126-08181607-S Height 8 mm In distribution
127-21-11161410 Depth 14 mm In distribution
127-10-10161412 Height 10 mm In distribution
127-10-14161412 Height 14 mm In distribution
127-20-08181610 Height 8 mm In distribution
255-10-09165500 Depth 55 mm In distribution
334-08141215-S Angle 15 ° In distribution
127-20-09201612 Height 9 mm In distribution
255-12-16266000 Width 26 mm In distribution
255-30-10186030 Depth 60 mm In distribution
127-11-10141200 Height 10 mm In distribution
127-11-13201612 Depth 16 mm In distribution
127-10-12201607 Length 16 mm In distribution
127-20-07201605 Length 16 mm In distribution
127-11-12181612 Angle 12 ° In distribution
127-21-07181607 Width 18 mm In distribution
127-21-11201612 Height 11 mm In distribution
127-21-05161400 Width 16 mm In distribution
127-10-06161410 Length 14 mm In distribution
127-10-09201612 Height 9 mm In distribution
127-10-13201607 Length 16 mm In distribution
127-20-14161415 Height 14 mm In distribution
127-11-14181610 Depth 16 mm In distribution
255-10-10267025 Depth 70 mm In distribution
129-10342420-S Angle 20 ° In distribution
127-21-08141212 Depth 12 mm In distribution
127-21-11141207 Angle 7 ° In distribution
127-11-06141215 Angle 15 ° In distribution
127-10-11201612 Angle 12 ° In distribution
127-11-10181612 Depth 16 mm In distribution
255-30-14186015 Depth 60 mm In distribution
127-20-08181612 Width 18 mm In distribution
127-10-12201600 Height 12 mm In distribution
127-20-11161415 Height 11 mm In distribution
127-11-07141207 Height 7 mm In distribution
127-21-13181612 Depth 16 mm In distribution
127-21-08201605 Width 20 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
Latitude-C AM™ Cervical Interbody Fusion System Degen Medical 1,529
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
Peridot-PT Anterior Cervical Intervertebral body fusion system Gbs Commonwealth Co., Ltd. 528

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
K251080 2025-07-03
K222973 2022-11-17
K181435 2018-08-21
K081730 2008-09-19

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