Copperhead
44 catalogue numbers from C3607, listed by Eminent Spine, United States, under Intervertebral Fusion Device With Bone Graft, Cervical. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
44catalogue 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 | Eminent Spine, United States |
|---|---|
| FDA product code | ODP |
| Device type | Intervertebral Fusion Device With Bone Graft, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K090064 |
| Record published | 2017-02-08 |
| Record revised | 2020-02-24 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| C3607 | In distribution | |
| C4512 | In distribution | |
| C4511 | In distribution | |
| C5512 | In distribution | |
| C4612 | In distribution | |
| C4609 | In distribution | |
| C5511 | In distribution | |
| C3608 | In distribution | |
| C3606 | In distribution | |
| C4606 | In distribution | |
| C3506 | In distribution | |
| C4510 | In distribution | |
| C5609 | In distribution | |
| C3605 | In distribution | |
| C4507 | In distribution | |
| C3509 | In distribution | |
| C4610 | In distribution | |
| C4608 | In distribution | |
| C5611 | In distribution | |
| C5606 | In distribution | |
| C4611 | In distribution | |
| C5607 | In distribution | |
| C4506 | In distribution | |
| C4508 | In distribution | |
| C5510 | In distribution | |
| C5508 | In distribution | |
| C3611 | In distribution | |
| C5507 | In distribution | |
| C4509 | In distribution | |
| C6010 | In distribution | |
| C3612 | In distribution | |
| C3510 | In distribution | |
| C3512 | In distribution | |
| C3610 | In distribution | |
| C5506 | In distribution | |
| C5605 | In distribution | |
| C5610 | In distribution | |
| C3507 | In distribution | |
| C4607 | In distribution | |
| C3511 | In distribution | |
| C5608 | In distribution | |
| C5509 | In distribution | |
| C4605 | In distribution | |
| C3508 | 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 |
|---|---|
| K212701 | 2023-02-06 |
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 |
|---|---|---|---|---|---|---|---|
| Spinal Solutions, LLC | 510(k) number | 2013-02-20 | Class II | Labeling design | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery. | 24 units | 2014-03-26 |
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.