Idys-C® ZP 3DTi
Anatomic Cervical Cage
7manufacturers in China registered for this device type
49catalogue numbers in this listing
1510(k) clearance
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 | Clariance, 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 | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K212562 |
| Record published | 2021-12-06 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 44581008-S | (W14 D13 H08 MM) | In distribution |
| 44582509-S | 18MM x 15MM H9MM | In distribution |
| 44053520-S | ( OD 3,5 MM L 20 MM ) | In distribution |
| 43707016 | Lg 14mm | In distribution |
| 43707014 | Lg 103mm | In distribution |
| 44714306 | 14MM x 13MM H6MM | In distribution |
| 44581006-S | (W14 D13 H06 MM) | In distribution |
| 44714006 | 14MM x 13MM H6MM | In distribution |
| 44053518-S | ( OD 3,5 MM L 18 MM ) | In distribution |
| 44581206-S | (W18 D15 H06 MM) | In distribution |
| 44710000 | Lg 135 mm | In distribution |
| 44582407-S | (W16 D14 H07 MM) | In distribution |
| 44054014-S | ( OD 4 MM L 14 MM ) | In distribution |
| 44714106 | 16MM x 14MM H5MM | In distribution |
| 44582309-S | (W14 D13 H09 MM) | In distribution |
| 44582405-S | (W16 D14 H05 MM) | In distribution |
| 43707004 | Lg 135mm | In distribution |
| 44710001 | Lg 203 mm | In distribution |
| 43707012 | Lg 103mm | In distribution |
| 44714408 | 16MM x 14MM H8MM | In distribution |
| 44581109-S | (W16 D14 H09 MM) | In distribution |
| 44054018-S | ( OD 4 MM L 18 MM ) | In distribution |
| 44700000 | Lg 140 mm | In distribution |
| 44581007-S | (W14 D13 H07 MM) | In distribution |
| 44714305 | 14MM x 13MM H5MM | In distribution |
| 44582409-S | (W16 D14 H09 MM) | In distribution |
| 44581106-S | (W16 D14 H06 MM) | In distribution |
| 44714009 | 14MM x 13MM H9MM | In distribution |
| 44714407 | 16MM x 14MM H7MM | In distribution |
| 44714008 | 14MM x 13MM H8MM | In distribution |
| 44702001 | Lg 250 mm | In distribution |
| 44700228 | Lg 250 mm | In distribution |
| 44581205-S | (W18 D15 H05 MM) | In distribution |
| 44714307 | 14MM x 13MM H7MM | In distribution |
| 44581209-S | (W18 D15 H09 MM) | In distribution |
| 44054020-S | ( OD 4 MM L 20 MM ) | In distribution |
| 44714109 | 16MM x 14MM H9MM | In distribution |
| 44053516-S | ( OD 3,5 MM L 16 MM ) | In distribution |
| 99783001 | Lg 200 mm | In distribution |
| 43707005 | Lg 103mm | In distribution |
| 44582308-S | (W14 D13 H08 MM) | In distribution |
| 44714506 | 18MM x 15MM H6MM | In distribution |
| 44581009-S | W14 D13 H09 MM) | In distribution |
| 44581105-S | (W16 D14 H05 MM) | In distribution |
| 44053514-S | ( OD 3,5 MM L 14 MM ) | In distribution |
| 44054016-S | ( OD 4 MM L 16 MM ) | In distribution |
| 44714107 | 16MM x 14MM H7MM | In distribution |
| 44582408-S | (W16 D14 H08 MM) | In distribution |
| 44714507 | 18MM x 15MM H7MM | 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 |
|---|---|
| K130853 | 2013-11-13 |
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.