IdentiTi II
IdentiTi II Cervical implants are spacers placed between neck vertebrae through an anterior surgical approach during spinal fusion. The family includes Cervical and Cervical Max Contact…
IdentiTi II Cervical implants are spacers placed between neck vertebrae through an anterior surgical approach during spinal fusion. The family includes Cervical and Cervical Max Contact versions, with different footprints, heights and lordotic angles to fit the treated anatomy.
The implants have an internal opening for bone graft and roughened endplate surfaces intended to resist expulsion. Cervical implants also incorporate a porous lattice that extends to their upper and lower surfaces and provides additional space for graft packing.
Listed Item
IdentiTi II Cervical Max Contact, 09 x 23 x 15mm, 12°
Material and Fixation
The spacers are additively manufactured from titanium powder using powder bed fusion. They are used with bone graft material and supplemental fixation. The system is intended for skeletally mature patients, with the treated cervical levels and graft selection determined within its specified use.
7manufacturers in China registered for this device type
137catalogue 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) | K251080 |
| Record published | 2025-08-14 |
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 | Angle 6 to 15 °; height 5 to 12 mm; width 14 to 23 mm; depth 12 to 16 mm; length 12 to 15 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 826-10181610-S | Angle 10 ° | In distribution |
| 826-12181610-S | Height 12 mm | In distribution |
| 837-10-08191206 | In distribution | |
| 836-06211406-S | Length 14 mm | In distribution |
| 826-08161415-S | Depth 14 mm | In distribution |
| 836-09231512-S | Length 15 mm | In distribution |
| 837-100 | In distribution | |
| 826-09201607-S | Width 20 mm | In distribution |
| 836-10211406-S | Height 10 mm | In distribution |
| 837-20-06231512 | In distribution | |
| 837-10-07231506 | In distribution | |
| 837-20-09191206 | In distribution | |
| 837-20-07191206 | In distribution | |
| 837-20-10211406 | In distribution | |
| 836-07231506-S | Height 7 mm | In distribution |
| 836-07211412-S | Length 14 mm | In distribution |
| 837-20-07211412 | In distribution | |
| 837-20-09211406 | In distribution | |
| 826-06201610-S | Angle 10 ° | In distribution |
| 837-10-09231506 | In distribution | |
| 836-08211412-S | Angle 12 ° | In distribution |
| 826-05161407-S | Width 16 mm | In distribution |
| 836-09211406-S | Width 21 mm | In distribution |
| 837-10-10231512 | In distribution | |
| 836-07191206-S | Length 12 mm | In distribution |
| 826-05181607-S | Height 5 mm | In distribution |
| 826-08141207-S | Angle 7 ° | In distribution |
| 837-20-10231512 | In distribution | |
| 837-10-09231512 | In distribution | |
| 826-09201610-S | Depth 16 mm | In distribution |
| 837-20-05191206 | In distribution | |
| 826-08161410-S | Depth 14 mm | In distribution |
| 836-08231506-S | Angle 6 ° | In distribution |
| 837-20-08231506 | In distribution | |
| 837-20-06211406 | In distribution | |
| 837-20-06191206 | In distribution | |
| 837-10-08231506 | In distribution | |
| 837-10-08211412 | In distribution | |
| 826-10161410-S | Depth 14 mm | In distribution |
| 837-20-10231506 | In distribution | |
| 836-08191206-S | Length 12 mm | In distribution |
| 826-06201607-S | Depth 16 mm | In distribution |
| 836-05191206-S | Angle 6 ° | In distribution |
| 837-20-07231506 | In distribution | |
| 826-06161410-S | Width 16 mm | In distribution |
| 837-10-09211412 | In distribution | |
| 837-20-09211412 | In distribution | |
| 826-09161407-S | Height 9 mm | In distribution |
| 836-10231512-S | Width 23 mm | In distribution |
| 826-10161415-S | Width 16 mm | In distribution |
| 837-10-06191206 | In distribution | |
| 836-06211412-S | Height 6 mm | In distribution |
| 826-12181607-S | Height 12 mm | In distribution |
| 836-10211412-S | Angle 12 ° | In distribution |
| 826-09141207-S | Height 9 mm | In distribution |
| 837-10-09191206 | In distribution | |
| 837-10-08211406 | In distribution | |
| 826-08181615-S | Angle 15 ° | In distribution |
| 826-07161410-S | Angle 10 ° | In distribution |
| 837-200 | In distribution | |
| 837-10-05191206 | In distribution | |
| 836-07231512-S | Length 15 mm | In distribution |
| 826-11181607-S | Height 11 mm | In distribution |
| 836-09191206-S | Angle 6 ° | In distribution |
| 836-08231512-S | Angle 12 ° | In distribution |
| 837-20-08211412 | In distribution | |
| 826-08201610-S | Angle 10 ° | In distribution |
| 826-10181615-S | Width 18 mm | In distribution |
| 826-10181607-S | Angle 7 ° | In distribution |
| 837-20-08191206 | In distribution | |
| 826-09161410-S | Height 9 mm | In distribution |
| 837-20-06211412 | In distribution | |
| 837-20-08211406 | In distribution | |
| 837-20-06231506 | In distribution | |
| 826-06181607-S | Width 18 mm | In distribution |
| 836-06231512-S | Height 6 mm | In distribution |
| 837-10-07191206 | In distribution | |
| 837-10-06211412 | In distribution | |
| 826-06181610-S | Depth 16 mm | In distribution |
| 836-09211412-S | Angle 12 ° | In distribution |
| 837-10-06231506 | In distribution | |
| 826-07161415-S | Angle 15 ° | In distribution |
| 826-06141207-S | Width 14 mm | In distribution |
| 837-10-07231512 | In distribution | |
| 837-10-10211406 | In distribution | |
| 836-06231506-S | Width 23 mm | In distribution |
| 826-11161410-S | Width 16 mm | In distribution |
| 826-07181607-S | Depth 16 mm | In distribution |
| 837-20-09231512 | In distribution | |
| 826-09161415-S | Depth 14 mm | In distribution |
| 836-08211406-S | Height 8 mm | In distribution |
| 837-202 | In distribution | |
| 826-07201610-S | Width 20 mm | In distribution |
| 837-201 | In distribution | |
| 837-10-06211406 | In distribution | |
| 836-09231506-S | Width 23 mm | In distribution |
| 837-10-09211406 | In distribution | |
| 837-10-07211412 | In distribution | |
| 837-20-09231506 | In distribution | |
| 836-10231506-S | Angle 6 ° | In distribution |
| 826-11141207-S | Height 11 mm | In distribution |
| 837-10-06231512 | In distribution | |
| 836-06191206-S | Height 6 mm | In distribution |
| 837-10-08231512 | In distribution | |
| 837-10-10231506 | In distribution | |
| 826-09181610-S | Angle 10 ° | In distribution |
| 826-10161407-S | Height 10 mm | In distribution |
| 826-07141207-S | Angle 7 ° | In distribution |
| 836-07211406-S | Angle 6 ° | In distribution |
| 826-07181610-S | Height 7 mm | In distribution |
| 837-20-07211406 | In distribution | |
| 837-10-10211412 | In distribution | |
| 837-212 | In distribution | |
| 826-07161407-S | Width 16 mm | In distribution |
| 826-07201607-S | Angle 7 ° | In distribution |
| 837-10-07211406 | In distribution | |
| 826-07201615-S | Width 20 mm | In distribution |
| 837-20-07231512 | In distribution | |
| 826-12161407-S | Height 12 mm | In distribution |
| 826-08201615-S | Height 8 mm | In distribution |
| 826-11181610-S | Angle 10 ° | In distribution |
| 826-08161407-S | Depth 14 mm | In distribution |
| 826-08201607-S | Depth 16 mm | In distribution |
| 837-211 | In distribution | |
| 826-12161410-S | Depth 14 mm | In distribution |
| 826-10141207-S | Width 14 mm | In distribution |
| 826-05141207-S | Angle 7 ° | In distribution |
| 837-20-10211412 | In distribution | |
| 826-12141207-S | Height 12 mm | In distribution |
| 826-11161407-S | Depth 14 mm | In distribution |
| 826-09181607-S | Angle 7 ° | In distribution |
| 826-09201615-S | Height 9 mm | In distribution |
| 826-09181615-S | Angle 15 ° | In distribution |
| 826-06161407-S | Angle 7 ° | In distribution |
| 837-20-08231512 | In distribution | |
| 826-08181610-S | Angle 10 ° | In distribution |
| 826-08181607-S | Depth 16 mm | In distribution |
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.