IdentiTi
The IdentiTi Cervical Standalone Interbody System is an integrated implant system for anterior cervical discectomy and fusion. It combines interbody spacers and bone screws in multiple…
The IdentiTi Cervical Standalone Interbody System is an integrated implant system for anterior cervical discectomy and fusion. It combines interbody spacers and bone screws in multiple configurations designed to accommodate anatomy.
The FDA indication covers adjunctive fusion at one or two contiguous levels from C2 to T1 in skeletally mature patients with degenerative disc disease. It specifies an open anterior approach, bone graft and the provided screw fixation, with no additional fixation required.
Listed Item
CERVICAL INTERFIXATED INSERTER TIP, FLUSH STOP, MEDIUM, 8-10 mm
Implant Design
The spacers combine porous commercially pure titanium and titanium alloy, with varying footprints and dimensions. The anterior face has two screw holes; the filing specifies autograft or cancellous or corticocancellous allogeneic graft.
5manufacturers in China registered for this device type
630catalogue numbers in this listing
1510(k) clearance
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.
| 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
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K202812 |
| Record published | 2021-12-05 |
| Record revised | 2025-07-14 (version 5) |
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 20 mm; depth 12 to 16 mm; height 5 to 12 mm; angle 5 to 15 °; outer diameter 3.5 to 4 mm; length 10 to 18 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 135-20-11161412 | Width 16 mm | In distribution |
| 135-6100-12 | In distribution | |
| 134-09161400-S | Width 16 mm | In distribution |
| 134-07201605-S | Width 20 mm | In distribution |
| 135-20-07181610 | Height 7 mm | In distribution |
| 135-10-07161400 | Width 16 mm | In distribution |
| 135-20-09201612 | Height 9 mm | In distribution |
| 135-20-06141207 | Width 14 mm | In distribution |
| 135-20-09201610 | Width 20 mm | In distribution |
| 134-08181615-S | Depth 16 mm | In distribution |
| 135-20-11141200 | Depth 12 mm | In distribution |
| 135-10-09141200 | Height 9 mm | In distribution |
| 134-06161410-S | Height 6 mm | In distribution |
| 135-6100-05 | In distribution | |
| 135-20-12141207 | Width 14 mm | In distribution |
| 135-155 | In distribution | |
| 135-10-10181605 | Width 18 mm | In distribution |
| 135-650-12 | In distribution | |
| 135-10-10141212 | Width 14 mm | In distribution |
| 135-20-05181605 | Depth 16 mm | In distribution |
| 134-08141215-S | Width 14 mm | In distribution |
| 135-20-10161405 | Angle 5 ° | In distribution |
| 135-650-09 | In distribution | |
| 135-10-10141215 | Height 10 mm | In distribution |
| 135-20-05181607 | Depth 16 mm | In distribution |
| 135-20-08201600 | Depth 16 mm | In distribution |
| 135-20-11181605 | Width 18 mm | In distribution |
| 134-05181607-S | Depth 16 mm | In distribution |
| 135-10-12161407 | Height 12 mm | In distribution |
| 134-08161412-S | Height 8 mm | In distribution |
| 135-6000-06 | In distribution | |
| 135-20-05161400 | Depth 14 mm | In distribution |
| 135-10-08181600 | Width 18 mm | In distribution |
| 135-10-07161405 | Angle 5 ° | In distribution |
| 135-10-08161415 | Height 8 mm | In distribution |
| 135-10-11161400 | Depth 14 mm | In distribution |
| 134-07201612-S | Height 7 mm | In distribution |
| 135-10-07141205 | Height 7 mm | In distribution |
| 135-10-08141215 | Height 8 mm | In distribution |
| 134-2-35-17 | Outer Diameter 3.5 mm | In distribution |
| 135-136 | In distribution | |
| 134-4-35-16 | Length 16 mm | In distribution |
| 134-05161400-S | Depth 14 mm | In distribution |
| 135-10-08141205 | Height 8 mm | In distribution |
| 135-6000-09 | In distribution | |
| 135-20-11201612 | Angle 12 ° | In distribution |
| 135-10-12181610 | Height 12 mm | In distribution |
| 135-20-07201610 | Width 20 mm | In distribution |
| 135-20-08141212 | Depth 12 mm | In distribution |
| 135-20-11161410 | Angle 10 ° | In distribution |
| 135-10-08161405 | Width 16 mm | In distribution |
| 134-08201615-S | Height 8 mm | In distribution |
| 134-10161407-S | Height 10 mm | In distribution |
| 135-20-09181600 | Height 9 mm | In distribution |
| 135-20-12141215 | Angle 15 ° | In distribution |
| 135-10-06161405 | Depth 14 mm | In distribution |
| 135-10-12141200 | Height 12 mm | In distribution |
| 134-06161407-S | Depth 14 mm | In distribution |
| 135-10-10201605 | Width 20 mm | In distribution |
| 135-10-10201600 | Width 20 mm | In distribution |
| 135-20-08181610 | Width 18 mm | In distribution |
| 134-3-40-14 | Outer Diameter 4.0 mm | In distribution |
| 135-10-09141205 | Width 14 mm | In distribution |
| 134-06201605-S | Depth 16 mm | In distribution |
| 134-06181600-S | Width 18 mm | In distribution |
| 135-10-11141200 | Width 14 mm | In distribution |
| 135-10-05141205 | Width 14 mm | In distribution |
| 135-20-06181607 | Height 6 mm | In distribution |
| 134-12201615-S | Depth 16 mm | In distribution |
| 135-10-12201612 | Angle 12 ° | In distribution |
| 134-08201600-S | Height 8 mm | In distribution |
| 134-4-40-14 | Length 14 mm | In distribution |
| 135-10-09161407 | Angle 7 ° | In distribution |
| 135-20-08201612 | Angle 12 ° | In distribution |
| 135-10-12161400 | Height 12 mm | In distribution |
| 134-09161405-S | Depth 14 mm | In distribution |
| 135-10-12181612 | Angle 12 ° | In distribution |
| 135-10-12141207 | Height 12 mm | In distribution |
| 135-20-12181612 | Height 12 mm | In distribution |
| 135-10-11201600 | Width 20 mm | In distribution |
| 134-09161415-S | Depth 14 mm | In distribution |
| 135-10-12201615 | Depth 16 mm | In distribution |
| 135-20-12161412 | Width 16 mm | In distribution |
| 135-20-07181607 | Width 18 mm | In distribution |
| 135-10-11141210 | Height 11 mm | In distribution |
| 134-07161412-S | Width 16 mm | In distribution |
| 135-137 | In distribution | |
| 135-10-09181605 | Width 18 mm | In distribution |
| 135-20-10201612 | Height 10 mm | In distribution |
| 135-10-06161410 | Width 16 mm | In distribution |
| 135-10-09181600 | Height 9 mm | In distribution |
| 135-10-10161400 | Depth 14 mm | In distribution |
| 135-20-05141210 | Angle 10 ° | In distribution |
| 135-10-12161415 | Height 12 mm | In distribution |
| 135-20-07141200 | Height 7 mm | In distribution |
| 135-10-10181610 | Depth 16 mm | In distribution |
| 134-1-35-14 | Outer Diameter 3.5 mm | In distribution |
| 134-05161405-S | Height 5 mm | In distribution |
| 135-20-07161412 | Angle 12 ° | In distribution |
| 134-08161415-S | Height 8 mm | In distribution |
| 135-10-09181612 | Width 18 mm | In distribution |
| 134-4-40-15 | Length 15 mm | In distribution |
| 135-20-06141200 | Width 14 mm | In distribution |
| 134-05141210-S | Width 14 mm | In distribution |
| 134-2-40-14 | Outer Diameter 4 mm | In distribution |
| 135-167 | In distribution | |
| 135-10-12141205 | Width 14 mm | In distribution |
| 135-10-05201605 | Width 20 mm | In distribution |
| 135-121 | In distribution | |
| 134-10201612-S | Width 20 mm | In distribution |
| 134-1-35-10 | Outer Diameter 3.5 mm | In distribution |
| 135-10-07161407 | Height 7 mm | In distribution |
| 134-11161412-S | Width 16 mm | In distribution |
| 135-10-10201610 | Depth 16 mm | In distribution |
| 134-12181615-S | Height 12 mm | In distribution |
| 134-4-40-17 | Length 17 mm | In distribution |
| 134-10201610-S | Height 10 mm | In distribution |
| 135-10-10161407 | Depth 14 mm | In distribution |
| 134-11141215-S | Width 14 mm | In distribution |
| 135-10-12161412 | Angle 12 ° | In distribution |
| 134-11201605-S | Height 11 mm | In distribution |
| 135-10-07181600 | Depth 16 mm | In distribution |
| 135-10-11181605 | Depth 16 mm | In distribution |
| 134-2-35-12 | Outer Diameter 3.5 mm | In distribution |
| 135-20-08201607 | Depth 16 mm | In distribution |
| 134-2-40-15 | Length 15 mm | In distribution |
| 134-2-40-18 | Outer Diameter 4 mm | In distribution |
| 134-07181600-S | Depth 16 mm | In distribution |
| 135-10-12201607 | Width 20 mm | In distribution |
| 134-07141215-S | Height 7 mm | In distribution |
| 135-10-11161407 | Depth 14 mm | In distribution |
| 134-09141207-S | Width 14 mm | In distribution |
| 135-20-12181615 | Depth 16 mm | In distribution |
| 135-10-12141212 | Width 14 mm | In distribution |
| 135-20-09181605 | Depth 16 mm | In distribution |
| 135-6000-08 | In distribution | |
| 135-10-06161412 | Height 6 mm | In distribution |
| 135-10-08161407 | Depth 14 mm | In distribution |
| 135-10-11201607 | Depth 16 mm | In distribution |
| 134-06141210-S | Width 14 mm | In distribution |
| 134-09181610-S | Depth 16 mm | In distribution |
| 135-20-11181600 | Height 11 mm | In distribution |
| 135-20-08201605 | Height 8 mm | In distribution |
| 135-10-06181605 | Width 18 mm | In distribution |
| 135-10-07181610 | Height 7 mm | In distribution |
| 134-12201600-S | Depth 16 mm | In distribution |
| 134-10181612-S | Width 18 mm | In distribution |
| 135-20-11141212 | Depth 12 mm | In distribution |
| 135-20-10181605 | Depth 16 mm | In distribution |
| 134-05141205-S | Width 14 mm | In distribution |
| 134-4-35-14 | Outer Diameter 3.5 mm | In distribution |
| 135-10-10141210 | Height 10 mm | In distribution |
| 135-20-05141200 | Depth 12 mm | In distribution |
| 135-20-12161407 | Width 16 mm | In distribution |
| 134-10141215-S | Width 14 mm | In distribution |
| 135-126 | In distribution | |
| 134-12141210-S | Height 12 mm | In distribution |
| 134-05201607-S | Depth 16 mm | In distribution |
| 135-10-07201612 | Width 20 mm | In distribution |
| 135-20-10161407 | Depth 14 mm | In distribution |
| 135-20-07181612 | Angle 12 ° | In distribution |
| 135-20-10201615 | Depth 16 mm | In distribution |
| 135-10-09201605 | Angle 5 ° | In distribution |
| 135-10-11181600 | Depth 16 mm | In distribution |
| 134-12141205-S | Width 14 mm | In distribution |
| 135-10-09141212 | Angle 12 ° | In distribution |
| 135-20-12181607 | Width 18 mm | In distribution |
| 134-06141207-S | Height 6 mm | In distribution |
| 134-10161400-S | Depth 14 mm | In distribution |
| 135-10-12201610 | Width 20 mm | In distribution |
| 134-2-35-14 | Outer Diameter 3.5 mm | In distribution |
| 135-20-07161410 | Height 7 mm | In distribution |
| 135-6100-08 | In distribution | |
| 135-10-05141200 | Depth 12 mm | In distribution |
| 135-10-06181607 | Width 18 mm | In distribution |
| 135-20-07181605 | Height 7 mm | In distribution |
| 134-06201607-S | Depth 16 mm | In distribution |
| 134-4-40-10 | Outer Diameter 4 mm | In distribution |
| 135-20-09181607 | Height 9 mm | In distribution |
| 134-09141215-S | Height 9 mm | In distribution |
| 135-20-05201600 | Width 20 mm | In distribution |
| 135-10-10141207 | Height 10 mm | In distribution |
| 135-10-07141210 | Depth 12 mm | In distribution |
| 135-20-10181607 | Angle 7 ° | In distribution |
| 135-10-11141207 | Angle 7 ° | In distribution |
| 134-3-35-12 | Outer Diameter 3.5 mm | In distribution |
| 134-08161410-S | Angle 10 ° | In distribution |
| 135-20-11141215 | Height 11 mm | In distribution |
| 135-20-07161405 | Width 16 mm | In distribution |
| 134-08201610-S | Depth 16 mm | In distribution |
| 134-2-40-13 | Outer Diameter 4 mm | In distribution |
| 134-07161410-S | Angle 10 ° | In distribution |
| 135-20-09141207 | Depth 12 mm | In distribution |
| 134-12161407-S | Height 12 mm | In distribution |
| 135-10-05161405 | Width 16 mm | In distribution |
| 134-07161415-S | Depth 14 mm | In distribution |
| 135-20-11201605 | Angle 5 ° | In distribution |
| 135-20-09201615 | Depth 16 mm | In distribution |
| 135-20-08181605 | Angle 5 ° | In distribution |
| 134-2-40-10 | Length 10 mm | In distribution |
| 135-10-09181607 | Width 18 mm | In distribution |
| 135-10-07201605 | Depth 16 mm | In distribution |
| 135-6100-06 | In distribution | |
| 135-135 | In distribution | |
| 135-10-08181610 | Height 8 mm | In distribution |
| 134-4-35-11 | Outer Diameter 3.5 mm | In distribution |
| 134-12181605-S | Height 12 mm | In distribution |
| 134-10161405-S | Height 10 mm | In distribution |
| 135-20-09141212 | Width 14 mm | In distribution |
| 135-20-08161410 | Angle 10 ° | In distribution |
| 135-10-10181607 | Depth 16 mm | In distribution |
| 135-600-12 | In distribution | |
| 135-10-05161400 | Height 5 mm | In distribution |
| 135-20-09141210 | Angle 10 ° | In distribution |
| 134-09161412-S | Width 16 mm | In distribution |
| 135-20-09201607 | Angle 7 ° | In distribution |
| 134-07141212-S | Height 7 mm | In distribution |
| 134-11181600-S | Width 18 mm | In distribution |
| 135-20-06181605 | Depth 16 mm | In distribution |
| 135-650-10 | In distribution | |
| 135-20-10141207 | Width 14 mm | In distribution |
| 134-4-40-16 | Outer Diameter 4 mm | In distribution |
| 134-12201612-S | Height 12 mm | In distribution |
| 135-20-11141207 | Angle 7 ° | In distribution |
| 135-10-07181607 | Width 18 mm | In distribution |
| 134-11201607-S | Height 11 mm | In distribution |
| 135-20-07161407 | Depth 14 mm | In distribution |
| 135-6100-11 | In distribution | |
| 135-20-08181615 | Width 18 mm | In distribution |
| 135-10-08141212 | Height 8 mm | In distribution |
| 135-20-07141215 | Depth 12 mm | In distribution |
| 134-05181605-S | Depth 16 mm | In distribution |
| 134-11161415-S | Depth 14 mm | In distribution |
| 135-10-11161415 | Angle 15 ° | In distribution |
| 134-2-40-16 | Outer Diameter 4 mm | In distribution |
| 134-12141207-S | Height 12 mm | In distribution |
| 135-151 | In distribution | |
| 135-20-08181600 | Height 8 mm | In distribution |
| 135-10-07201607 | Height 7 mm | In distribution |
| 135-20-08201615 | Height 8 mm | In distribution |
| 134-4-35-17 | Length 17 mm | In distribution |
| 134-12201605-S | Width 20 mm | In distribution |
| 135-20-08181612 | Depth 16 mm | In distribution |
| 134-11201612-S | Depth 16 mm | In distribution |
| 134-06141205-S | Height 6 mm | In distribution |
| 134-06181605-S | Height 6 mm | In distribution |
| 134-09201610-S | Depth 16 mm | In distribution |
| 135-20-07181600 | Height 7 mm | In distribution |
| 134-3-35-16 | Length 16 mm | In distribution |
| 134-12141200-S | Depth 12 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dolomite | Astura Medical | 607 |
| CoRoent | Nuvasive, Inc. | 580 |
| Aeon-C | Diomedical Co., Ltd. | 508 |
| Tomcat™ Cervical Spinal System | Choice Spine, LP | 468 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202812 | 2020-12-18 |
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.