Spira®-C Open Matrix Cervical Interbody
12.5mm x 16mm, 12° Lordotic, 10mm
7manufacturers in China registered for this device type
152catalogue numbers in this listing
3510(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 | Camber Spine Technologies, 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) | K172446 |
| Record published | 2022-11-02 |
| Record revised | 2020-02-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Depth 12.5 to 16 mm; width 14 to 20 mm; height 5 to 12 mm; angle 7 to 12 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPC-1318-1209 | In distribution | |
| SPC-12516-AN06 | Depth 12.5 mm | In distribution |
| SPC-1620-0709 | Depth 16 mm | In distribution |
| SPC-1518-0712 | Depth 15 mm | In distribution |
| SPC-1314-0707 | Height 7 mm | In distribution |
| SPC-1318-AN09 | Depth 13 mm | In distribution |
| SPC-1416-1212 | Depth 14 mm | In distribution |
| SPC-01318-0708 | In distribution | |
| SPC-1518-1212 | Depth 15 mm | In distribution |
| SPC-1620-0706 | Depth 16 mm | In distribution |
| SPC-1518-AN06 | Depth 15 mm | In distribution |
| SPC-1318-1211 | Depth 13 mm | In distribution |
| SPC-12145-0708 | In distribution | |
| SPC-1518-AN09 | Depth 15 mm | In distribution |
| SPC-1314-1205 | Height 5 mm | In distribution |
| SPC-1518-0711 | Depth 15 mm | In distribution |
| SPC-12516-1210 | Depth 12.5 mm | In distribution |
| SPC-12516-AN07 | Depth 12.5 mm | In distribution |
| SPC-1620-1208 | Depth 16 mm | In distribution |
| SPC-1416-AN12 | Depth 14 mm | In distribution |
| SPC-01318-0707 | In distribution | |
| SPC-1620-AN12 | Depth 16 mm | In distribution |
| SPC-1318-1206 | Depth 13 mm | In distribution |
| SPC-01318-0709 | In distribution | |
| SPC-1314-0705 | Height 5 mm | In distribution |
| SPC-1314-AN09 | Height 9 mm | In distribution |
| SPC-1416-1208 | Depth 14 mm | In distribution |
| SPC-12516-0711 | In distribution | |
| SPC-12145-0707 | In distribution | |
| SPC-12516-AN12 | Depth 12.5 mm | In distribution |
| SPC-1620-0710 | Depth 16 mm | In distribution |
| SPC-1318-AN07 | Depth 13 mm | In distribution |
| SPC-12516-AN05 | Depth 12.5 mm | In distribution |
| SPC-1318-AN08 | Depth 13 mm | In distribution |
| SPC-1416-0707 | Angle 7 ° | In distribution |
| SPC-1620-AN10 | Depth 16 mm | In distribution |
| SPC-1620-AN11 | Depth 16 mm | In distribution |
| SPC-1318-1207 | Depth 13 mm | In distribution |
| SPC-1416-AN07 | Height 7 mm | In distribution |
| SPC-01318-0706 | In distribution | |
| SPC-12516-AN08 | Depth 12.5 mm | In distribution |
| SPC-1318-AN06 | Depth 13 mm | In distribution |
| SPC-1416-AN08 | Depth 14 mm | In distribution |
| SPC-1318-1212 | Depth 13 mm | In distribution |
| SPC-12516-0710 | In distribution | |
| SPC-1416-1209 | Angle 12 ° | In distribution |
| SPC-1518-1207 | Depth 15 mm | In distribution |
| SPC-1416-0706 | Depth 14 mm | In distribution |
| SPC-12516-0709 | In distribution | |
| SPC-1620-AN09 | Depth 16 mm | In distribution |
| SPC-1416-0708 | Depth 14 mm | In distribution |
| SPC-1518-AN08 | Depth 15 mm | In distribution |
| SPC-12145-0706 | In distribution | |
| SPC-1518-AN05 | Depth 15 mm | In distribution |
| SPC-1314-1211 | Height 11 mm | In distribution |
| SPC-1314-1209 | Height 9 mm | In distribution |
| SPC-1416-1211 | Angle 12 ° | In distribution |
| SPC-12516-1209 | Depth 12.5 mm | In distribution |
| SPC-1416-0705 | Angle 7 ° | In distribution |
| SPC-1416-AN05 | Height 5 mm | In distribution |
| SPC-1416-0710 | Depth 14 mm | In distribution |
| SPC-12145-0709 | In distribution | |
| SPC-1416-1205 | Angle 12 ° | In distribution |
| SPC-1416-AN11 | Height 11 mm | In distribution |
| SPC-1620-1206 | Depth 16 mm | In distribution |
| SPC-1620-0712 | Depth 16 mm | In distribution |
| SPC-1314-0708 | Depth 13 mm | In distribution |
| SPC-1518-1211 | Depth 15 mm | In distribution |
| SPC-1620-AN06 | Depth 16 mm | In distribution |
| SPC-1314-0711 | Height 11 mm | In distribution |
| SPC-1314-0709 | Height 9 mm | In distribution |
| SPC-1416-1210 | Depth 14 mm | In distribution |
| SPC-12516-0712 | In distribution | |
| SPC-1318-1210 | Depth 13 mm | In distribution |
| SPC-1620-0705 | Depth 16 mm | In distribution |
| SPC-1314-AN10 | Depth 13 mm | In distribution |
| SPC-1518-AN11 | Depth 15 mm | In distribution |
| SPC-1318-AN12 | Depth 13 mm | In distribution |
| SPC-12516-AN11 | Depth 12.5 mm | In distribution |
| SPC-01318-0710 | In distribution | |
| SPC-12516-1211 | Depth 12.5 mm | In distribution |
| SPC-1518-0710 | Depth 15 mm | In distribution |
| SPC-1314-1210 | Depth 13 mm | In distribution |
| SPC-1518-1206 | Depth 15 mm | In distribution |
| SPC-12516-1206 | Depth 12.5 mm | In distribution |
| SPC-1518-1205 | Depth 15 mm | In distribution |
| SPC-1416-1207 | Angle 12 ° | In distribution |
| SPC-1518-0708 | Depth 15 mm | In distribution |
| SPC-1518-0707 | Width 18 mm | In distribution |
| SPC-1416-0712 | Depth 14 mm | In distribution |
| SPC-1314-0710 | Depth 13 mm | In distribution |
| SPC-1318-1205 | Depth 13 mm | In distribution |
| SPC-1518-0705 | Angle 7 ° | In distribution |
| SPC-1318-AN11 | Depth 13 mm | In distribution |
| SPC-1620-0708 | Depth 16 mm | In distribution |
| SPC-1314-AN12 | Depth 13 mm | In distribution |
| SPC-1314-AN07 | Height 7 mm | In distribution |
| SPC-12516-0705 | In distribution | |
| SPC-12145-0710 | In distribution | |
| SPC-1620-1211 | Depth 16 mm | In distribution |
| SPC-12516-AN10 | Depth 12.5 mm | In distribution |
| SPC-1318-AN10 | Depth 13 mm | In distribution |
| SPC-1518-AN12 | Depth 15 mm | In distribution |
| SPC-1518-1208 | Depth 15 mm | In distribution |
| SPC-1620-0707 | Depth 16 mm | In distribution |
| SPC-1518-1209 | Depth 15 mm | In distribution |
| SPC-1314-0712 | Depth 13 mm | In distribution |
| SPC-1620-AN08 | Depth 16 mm | In distribution |
| SPC-1416-AN09 | Height 9 mm | In distribution |
| SPC-12516-0706 | In distribution | |
| SPC-1518-0706 | Width 18 mm | In distribution |
| SPC-1620-AN05 | Depth 16 mm | In distribution |
| SPC-1620-1207 | Depth 16 mm | In distribution |
| SPC-1620-AN07 | Depth 16 mm | In distribution |
| SPC-1416-0709 | Angle 7 ° | In distribution |
| SPC-12516-1207 | Depth 12.5 mm | In distribution |
| SPC-01318-0705 | In distribution | |
| SPC-1518-0709 | Width 18 mm | In distribution |
| SPC-1518-AN10 | Depth 15 mm | In distribution |
| SPC-12516-0707 | In distribution | |
| SPC-1416-0711 | Angle 7 ° | In distribution |
| SPC-1518-AN07 | Depth 15 mm | In distribution |
| SPC-1620-1209 | Depth 16 mm | In distribution |
| SPC-1314-1208 | Depth 13 mm | In distribution |
| SPC-1416-AN06 | Depth 14 mm | In distribution |
| SPC-12516-1205 | Depth 12.5 mm | In distribution |
| SPC-1314-AN06 | Depth 13 mm | In distribution |
| SPC-12516-1208 | Depth 12.5 mm | In distribution |
| SPC-1416-AN10 | Depth 14 mm | In distribution |
| SPC-1318-1208 | Depth 13 mm | In distribution |
| SPC-1620-0711 | Depth 16 mm | In distribution |
| SPC-1416-1206 | Depth 14 mm | In distribution |
| SPC-1314-AN08 | Depth 13 mm | In distribution |
| SPC-1314-AN11 | Height 11 mm | In distribution |
| SPC-1314-0706 | Depth 13 mm | In distribution |
| SPC-1314-1212 | Depth 13 mm | In distribution |
| SPC-1314-1206 | Depth 13 mm | In distribution |
| SPC-12516-AN09 | Depth 12.5 mm | In distribution |
| SPC-01318-0712 | In distribution | |
| SPC-12516-0708 | In distribution | |
| SPC-1314-AN05 | Height 5 mm | In distribution |
| SPC-1620-1205 | Depth 16 mm | In distribution |
| SPC-12145-0712 | In distribution | |
| SPC-12145-0705 | In distribution | |
| SPC-01318-0711 | In distribution | |
| SPC-12145-0711 | In distribution | |
| SPC-1620-1212 | Depth 16 mm | In distribution |
| SPC-1314-1207 | Height 7 mm | In distribution |
| SPC-1620-1210 | Depth 16 mm | In distribution |
| SPC-1318-AN05 | Depth 13 mm | In distribution |
| SPC-1518-1210 | Depth 15 mm | In distribution |
| SPC-12516-1212 | Depth 12.5 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172446 | 2017-11-07 |
| K170550 | 2017-07-13 |
| K133529 | 2014-03-20 |
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.