Atec Porous Ti Interbody System
Cervical Trial, 11 x 18 x 16 - 15°
7manufacturers in China registered for this device type
354catalogue 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.
| 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
| 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) | K183705 |
| Record published | 2020-03-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Width 12 to 22 mm; height 3 to 12 mm; length 12 to 19 mm; angle 5 to 15 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 115-06121215 | Width 12 mm | In distribution |
| 115-12141207 | Angle 7 ° | In distribution |
| 115-11181615 | Angle 15 ° | In distribution |
| 115-09181615 | Width 18 mm | In distribution |
| 115-08161415 | Height 8 mm | In distribution |
| 115-10181600 | Length 16 mm | In distribution |
| 115-06201810 | Angle 10 ° | In distribution |
| 115-09141207 | Width 14 mm | In distribution |
| 115-09141205 | Angle 5 ° | In distribution |
| 115-03221910 | Width 22 mm | In distribution |
| 115-05181607 | Height 5 mm | In distribution |
| 115-08201812 | Width 20 mm | In distribution |
| 115-06141212 | Angle 12 ° | In distribution |
| 115-10221912 | Height 10 mm | In distribution |
| 115-11121210 | Angle 10 ° | In distribution |
| 115-07161415 | Width 16 mm | In distribution |
| 115-08221905 | Angle 5 ° | In distribution |
| 115-05141205 | Angle 5 ° | In distribution |
| 115-07201800 | Height 7 mm | In distribution |
| 115-03141210 | Height 3 mm | In distribution |
| 115-03121205 | Length 12 mm | In distribution |
| 115-08201810 | Width 20 mm | In distribution |
| 115-10161405 | Length 14 mm | In distribution |
| 115-09201807 | Height 9 mm | In distribution |
| 115-04181605 | Angle 5 ° | In distribution |
| 115-09161415 | Width 16 mm | In distribution |
| 115-12161407 | Width 16 mm | In distribution |
| 115-10181612 | Height 10 mm | In distribution |
| 115-05141210 | Height 5 mm | In distribution |
| 115-10161415 | Height 10 mm | In distribution |
| 115-10141215 | Width 14 mm | In distribution |
| 115-11201812 | Width 20 mm | In distribution |
| 115-05161412 | Angle 12 ° | In distribution |
| 115-11181607 | Angle 7 ° | In distribution |
| 115-11141205 | Width 14 mm | In distribution |
| 115-04161410 | Height 4 mm | In distribution |
| 115-06221907 | Height 6 mm | In distribution |
| 115-09161405 | Length 14 mm | In distribution |
| 115-08221912 | Height 8 mm | In distribution |
| 115-07121215 | Angle 15 ° | In distribution |
| 115-12201800 | Height 12 mm | In distribution |
| 115-12121205 | Width 12 mm | In distribution |
| 115-11221912 | Angle 12 ° | In distribution |
| 115-11221910 | Angle 10 ° | In distribution |
| 115-06201807 | Length 18 mm | In distribution |
| 115-04141200 | Width 14 mm | In distribution |
| 115-07181607 | Width 18 mm | In distribution |
| 115-12121210 | Width 12 mm | In distribution |
| 115-04141205 | Height 4 mm | In distribution |
| 115-05201810 | Height 5 mm | In distribution |
| 115-07121205 | Width 12 mm | In distribution |
| 115-07161400 | Length 14 mm | In distribution |
| 115-09201810 | Angle 10 ° | In distribution |
| 115-12181610 | Length 16 mm | In distribution |
| 115-11121200 | Height 11 mm | In distribution |
| 115-07221907 | Length 19 mm | In distribution |
| 115-03201805 | Width 20 mm | In distribution |
| 115-10221910 | Angle 10 ° | In distribution |
| 115-11221900 | Length 19 mm | In distribution |
| 115-03161410 | Height 3 mm | In distribution |
| 115-06221905 | Angle 5 ° | In distribution |
| 115-09141212 | Height 9 mm | In distribution |
| 115-05161415 | Height 5 mm | In distribution |
| 115-07221912 | Length 19 mm | In distribution |
| 115-09121212 | Width 12 mm | In distribution |
| 115-10181615 | Width 18 mm | In distribution |
| 115-07181610 | Angle 10 ° | In distribution |
| 115-11181600 | Width 18 mm | In distribution |
| 115-11201807 | Height 11 mm | In distribution |
| 115-11161405 | Width 16 mm | In distribution |
| 115-04181615 | Length 16 mm | In distribution |
| 115-11201810 | Length 18 mm | In distribution |
| 115-06121207 | Length 12 mm | In distribution |
| 115-05141207 | Length 12 mm | In distribution |
| 115-07141200 | Length 12 mm | In distribution |
| 115-04121205 | Angle 5 ° | In distribution |
| 115-04121210 | Width 12 mm | In distribution |
| 115-06181607 | Height 6 mm | In distribution |
| 115-04221915 | Width 22 mm | In distribution |
| 115-08181612 | Width 18 mm | In distribution |
| 115-06161405 | Height 6 mm | In distribution |
| 115-05201807 | Height 5 mm | In distribution |
| 115-06161400 | Height 6 mm | In distribution |
| 115-07141210 | Width 14 mm | In distribution |
| 115-03221907 | Angle 7 ° | In distribution |
| 115-06121212 | Height 6 mm | In distribution |
| 115-04201815 | Height 4 mm | In distribution |
| 115-03161415 | Angle 15 ° | In distribution |
| 115-06161412 | Height 6 mm | In distribution |
| 115-05141200 | Length 12 mm | In distribution |
| 115-05181605 | Angle 5 ° | In distribution |
| 115-04121215 | Width 12 mm | In distribution |
| 115-12201805 | Length 18 mm | In distribution |
| 115-05221907 | Height 5 mm | In distribution |
| 115-03161405 | Length 14 mm | In distribution |
| 115-11181610 | Angle 10 ° | In distribution |
| 115-05221915 | Width 22 mm | In distribution |
| 115-09161400 | Height 9 mm | In distribution |
| 115-12221910 | Angle 10 ° | In distribution |
| 115-10201800 | Height 10 mm | In distribution |
| 115-08141215 | Width 14 mm | In distribution |
| 115-10201812 | Height 10 mm | In distribution |
| 115-04121207 | Width 12 mm | In distribution |
| 115-08161400 | Height 8 mm | In distribution |
| 115-03201815 | Angle 15 ° | In distribution |
| 115-11221905 | Height 11 mm | In distribution |
| 115-04161415 | Height 4 mm | In distribution |
| 115-06221915 | Angle 15 ° | In distribution |
| 115-09161412 | Width 16 mm | In distribution |
| 115-06221910 | Height 6 mm | In distribution |
| 115-09221912 | Length 19 mm | In distribution |
| 115-11141200 | Length 12 mm | In distribution |
| 115-10121215 | Length 12 mm | In distribution |
| 115-05161400 | Length 14 mm | In distribution |
| 115-08161407 | Angle 7 ° | In distribution |
| 115-10221905 | Height 10 mm | In distribution |
| 115-05221900 | Width 22 mm | In distribution |
| 115-05121207 | Width 12 mm | In distribution |
| 115-10121200 | Height 10 mm | In distribution |
| 115-03181610 | Height 3 mm | In distribution |
| 115-08221910 | Height 8 mm | In distribution |
| 115-07141212 | Length 12 mm | In distribution |
| 115-10161400 | Height 10 mm | In distribution |
| 115-12201807 | Height 12 mm | In distribution |
| 115-11141210 | Width 14 mm | In distribution |
| 115-09181600 | Height 9 mm | In distribution |
| 115-08201805 | Height 8 mm | In distribution |
| 115-05121215 | Height 5 mm | In distribution |
| 115-07181612 | Angle 12 ° | In distribution |
| 115-12141210 | Width 14 mm | In distribution |
| 115-08181610 | Height 8 mm | In distribution |
| 115-11181612 | Height 11 mm | In distribution |
| 115-08121200 | Height 8 mm | In distribution |
| 115-06181615 | Angle 15 ° | In distribution |
| 115-08121215 | Width 12 mm | In distribution |
| 115-05181615 | Length 16 mm | In distribution |
| 115-08121212 | Width 12 mm | In distribution |
| 115-10181610 | Height 10 mm | In distribution |
| 115-07221915 | Length 19 mm | In distribution |
| 115-09141215 | Width 14 mm | In distribution |
| 115-06121200 | Width 12 mm | In distribution |
| 115-08161412 | Length 14 mm | In distribution |
| 115-09181610 | Height 9 mm | In distribution |
| 115-06181605 | Angle 5 ° | In distribution |
| 115-03121207 | Height 3 mm | In distribution |
| 115-10201805 | Width 20 mm | In distribution |
| 115-06201805 | Height 6 mm | In distribution |
| 115-05201812 | Width 20 mm | In distribution |
| 115-08221907 | Height 8 mm | In distribution |
| 115-05181612 | Height 5 mm | In distribution |
| 115-10121212 | Height 10 mm | In distribution |
| 115-10141210 | Angle 10 ° | In distribution |
| 115-12181612 | Width 18 mm | In distribution |
| 115-07121207 | Angle 7 ° | In distribution |
| 115-04181607 | Height 4 mm | In distribution |
| 115-04221905 | Angle 5 ° | In distribution |
| 115-04181612 | Angle 12 ° | In distribution |
| 115-09221900 | Height 9 mm | In distribution |
| 115-05181600 | Length 16 mm | In distribution |
| 115-06181612 | Height 6 mm | In distribution |
| 115-04201805 | Angle 5 ° | In distribution |
| 115-03121212 | Width 12 mm | In distribution |
| 115-08201815 | Length 18 mm | In distribution |
| 115-09121205 | Width 12 mm | In distribution |
| 115-06141215 | Length 12 mm | In distribution |
| 115-08141205 | Width 14 mm | In distribution |
| 115-04181600 | Height 4 mm | In distribution |
| 115-06201815 | Angle 15 ° | In distribution |
| 115-09141210 | Length 12 mm | In distribution |
| 115-07201810 | Length 18 mm | In distribution |
| 115-09221915 | Width 22 mm | In distribution |
| 115-09221907 | Width 22 mm | In distribution |
| 115-11161400 | Height 11 mm | In distribution |
| 115-06121210 | Height 6 mm | In distribution |
| 115-11161407 | Length 14 mm | In distribution |
| 115-03201807 | Angle 7 ° | In distribution |
| 115-03141205 | Angle 5 ° | In distribution |
| 115-04201807 | Height 4 mm | In distribution |
| 115-08201807 | Width 20 mm | In distribution |
| 115-07161407 | Height 7 mm | In distribution |
| 115-06121205 | Length 12 mm | In distribution |
| 115-12181605 | Angle 5 ° | In distribution |
| 115-11121207 | Height 11 mm | In distribution |
| 115-06181600 | Length 16 mm | In distribution |
| 115-10181605 | Angle 5 ° | In distribution |
| 115-10161407 | Length 14 mm | In distribution |
| 115-12221907 | Angle 7 ° | In distribution |
| 115-09121207 | Angle 7 ° | In distribution |
| 115-04141210 | Width 14 mm | In distribution |
| 115-03141212 | Length 12 mm | In distribution |
| 115-05221905 | Height 5 mm | In distribution |
| 115-12181607 | Angle 7 ° | In distribution |
| 115-12141200 | Length 12 mm | In distribution |
| 115-08161405 | Angle 5 ° | In distribution |
| 115-09161407 | Width 16 mm | In distribution |
| 115-04141212 | Height 4 mm | In distribution |
| 115-04161407 | Width 16 mm | In distribution |
| 115-12141205 | Angle 5 ° | In distribution |
| 115-03141207 | Height 3 mm | In distribution |
| 115-12221912 | Length 19 mm | In distribution |
| 115-12161412 | Angle 12 ° | In distribution |
| 115-11201815 | Height 11 mm | In distribution |
| 115-10141207 | Angle 7 ° | In distribution |
| 115-04161400 | Width 16 mm | In distribution |
| 115-04121200 | Height 4 mm | In distribution |
| 115-06161415 | Width 16 mm | In distribution |
| 115-11161412 | Height 11 mm | In distribution |
| 115-12161415 | Length 14 mm | In distribution |
| 115-12121200 | Width 12 mm | In distribution |
| 115-11221915 | Angle 15 ° | In distribution |
| 115-07181605 | Angle 5 ° | In distribution |
| 115-07201805 | Height 7 mm | In distribution |
| 115-10141200 | Width 14 mm | In distribution |
| 115-07221905 | Length 19 mm | In distribution |
| 115-03221905 | Width 22 mm | In distribution |
| 115-03161407 | Height 3 mm | In distribution |
| 115-05121210 | Angle 10 ° | In distribution |
| 115-10181607 | Length 16 mm | In distribution |
| 115-04201812 | Height 4 mm | In distribution |
| 115-05161405 | Length 14 mm | In distribution |
| 115-07221900 | Width 22 mm | In distribution |
| 115-03201810 | Width 20 mm | In distribution |
| 115-06141207 | Width 14 mm | In distribution |
| 115-08141200 | Width 14 mm | In distribution |
| 115-08161410 | Length 14 mm | In distribution |
| 115-12201815 | Height 12 mm | In distribution |
| 115-04201810 | Height 4 mm | In distribution |
| 115-07201807 | Height 7 mm | In distribution |
| 115-10121207 | Length 12 mm | In distribution |
| 115-04161412 | Angle 12 ° | In distribution |
| 115-06201812 | Length 18 mm | In distribution |
| 115-04121212 | Height 4 mm | In distribution |
| 115-08221900 | Length 19 mm | In distribution |
| 115-03121215 | Width 12 mm | In distribution |
| 115-11141215 | Height 11 mm | In distribution |
| 115-09201805 | Width 20 mm | In distribution |
| 115-12181615 | Angle 15 ° | In distribution |
| 115-05201815 | Width 20 mm | In distribution |
| 115-12181600 | Length 16 mm | In distribution |
| 115-12221900 | Length 19 mm | In distribution |
| 115-05121205 | Width 12 mm | In distribution |
| 115-09181612 | Height 9 mm | In distribution |
| 115-04141207 | Width 14 mm | In distribution |
| 115-09141200 | Height 9 mm | In distribution |
| 115-09221910 | Width 22 mm | In distribution |
| 115-08121205 | Angle 5 ° | In distribution |
| 115-12221905 | Width 22 mm | In distribution |
| 115-09121200 | Height 9 mm | In distribution |
| 115-11221907 | Length 19 mm | In distribution |
| 115-08141212 | Length 12 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same 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
| 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.