InTice™ -C Porous Ti Cervical Interbody System
InTice™-C 11mm x 14mm x 10mm Parallel-Convex
7manufacturers in China registered for this device type
48catalogue numbers in this listing
1recall
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 | Xtant Medical Holdings, 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 |
| 510(k) | K173832 |
| Record published | 2019-11-18 |
| Record revised | 2025-07-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Height 5 to 12 mm; width 14 to 18 mm; length 11 to 15 mm; angle 7 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X098-0605-STR | Height 5 mm | In distribution |
| X098-0410-STR | Height 10 mm | In distribution |
| X098-0406-STR | Height 6 mm | In distribution |
| X098-0612-STR | Height 12 mm | In distribution |
| X098-0510-STR | Height 10 mm | In distribution |
| X098-0509-STR | Height 9 mm | In distribution |
| X098-0109-STR | Angle 7 ° | In distribution |
| X098-0107-STR | Angle 7 ° | In distribution |
| X098-0606-STR | Height 6 mm | In distribution |
| X098-0209-STR | Angle 7 ° | In distribution |
| X098-0508-STR | Height 8 mm | In distribution |
| X098-0412-STR | Height 12 mm | In distribution |
| X098-0306-STR | Angle 7 ° | In distribution |
| X098-0112-STR | Angle 7 ° | In distribution |
| X098-0409-STR | Height 9 mm | In distribution |
| X098-0207-STR | Angle 7 ° | In distribution |
| X098-0206-STR | Angle 7 ° | In distribution |
| X098-0407-STR | Height 7 mm | In distribution |
| X098-0211-STR | Angle 7 ° | In distribution |
| X098-0111-STR | Angle 7 ° | In distribution |
| X098-0512-STR | Height 12 mm | In distribution |
| X098-0607-STR | Height 7 mm | In distribution |
| X098-0511-STR | Height 11 mm | In distribution |
| X098-0311-STR | Angle 7 ° | In distribution |
| X098-0106-STR | Angle 7 ° | In distribution |
| X098-0205-STR | Angle 7 ° | In distribution |
| X098-0405-STR | Height 5 mm | In distribution |
| X098-0305-STR | Angle 7 ° | In distribution |
| X098-0212-STR | Angle 7 ° | In distribution |
| X098-0312-STR | Angle 7 ° | In distribution |
| X098-0609-STR | Height 9 mm | In distribution |
| X098-0308-STR | Angle 7 ° | In distribution |
| X098-0208-STR | Angle 7 ° | In distribution |
| X098-0611-STR | Height 11 mm | In distribution |
| X098-0610-STR | Height 10 mm | In distribution |
| X098-0110-STR | Angle 7 ° | In distribution |
| X098-0608-STR | Height 8 mm | In distribution |
| X098-0506-STR | Height 6 mm | In distribution |
| X098-0108-STR | Angle 7 ° | In distribution |
| X098-0310-STR | Angle 7 ° | In distribution |
| X098-0105-STR | Angle 7 ° | In distribution |
| X098-0408-STR | Height 8 mm | In distribution |
| X098-0309-STR | Angle 7 ° | In distribution |
| X098-0307-STR | Angle 7 ° | In distribution |
| X098-0210-STR | Angle 7 ° | In distribution |
| X098-0411-STR | Height 11 mm | In distribution |
| X098-0507-STR | Height 7 mm | In distribution |
| X098-0505-STR | Height 5 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Xtant Medical Holdings, Inc. | 510(k) number | 2020-09-30 | Class III | Labeling mix-ups | Cervical Implants contain a label that incorrectly identifies the grade of titanium used. | 508 units | 2021-05-21 |
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.