Cervical Interbody Fusion Device
PEEK Cervical Spacer 17x14x10 mm Lordotic 6 degrees
7manufacturers in China registered for this device type
53catalogue 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 | Maxim Surgical, 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) | K123206 |
| Record published | 2017-07-21 |
| Record revised | 2022-09-16 (version 9) |
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 |
| Sizes | Height 5 to 10 mm; length 15 to 17 mm; width 13 to 14 mm; angle 6 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CT1708-0 | Height 8 mm | In distribution |
| CT1705-0 | Length 17 mm | In distribution |
| CT1506-0 | Height 6 mm | In distribution |
| CT1508-0 | Height 8 mm | In distribution |
| CR1517-10 | Height 10 mm | In distribution |
| 1707N | Length 17 mm | In distribution |
| CT1707 | Length 17 mm | In distribution |
| CR1517-05 | Height 5 mm | In distribution |
| CT1507-0 | Length 15 mm | In distribution |
| CT1706 | Height 6 mm | In distribution |
| CT1706-0 | Height 6 mm | In distribution |
| CT1709-0 | Length 17 mm | In distribution |
| CI1001 | In distribution | |
| 1708N | Height 8 mm | In distribution |
| CR1517-07 | Height 7 mm | In distribution |
| CR1517-08 | Height 8 mm | In distribution |
| CT1508 | Length 15 mm | In distribution |
| 1707L | Height 7 mm | In distribution |
| FP2001 | In distribution | |
| 1506L | Angle 6 ° | In distribution |
| 1710L | Angle 6 ° | In distribution |
| CR1517-09 | Height 9 mm | In distribution |
| CT1509-0 | Length 15 mm | In distribution |
| CT1510 | Length 15 mm | In distribution |
| 1509L | Height 9 mm | In distribution |
| 1508L | Angle 6 ° | In distribution |
| CT1510-0 | Height 10 mm | In distribution |
| 1506N | Height 6 mm | In distribution |
| CT1506 | Length 15 mm | In distribution |
| CT1709 | Length 17 mm | In distribution |
| 1507N | Length 15 mm | In distribution |
| 1510L | Angle 6 ° | In distribution |
| 1510N | Height 10 mm | In distribution |
| CT1708 | Height 8 mm | In distribution |
| 1507L | Height 7 mm | In distribution |
| CT1509 | Height 9 mm | In distribution |
| 1706L | Angle 6 ° | In distribution |
| CR1517-06 | Height 6 mm | In distribution |
| MF2004c-01 | In distribution | |
| 1509N | Length 15 mm | In distribution |
| 179-040-001 | In distribution | |
| 1706N | Height 6 mm | In distribution |
| CT1710-0 | Height 10 mm | In distribution |
| CT1707-0 | Length 17 mm | In distribution |
| 1709L | Height 9 mm | In distribution |
| 1710N | Height 10 mm | In distribution |
| 1708L | Angle 6 ° | In distribution |
| 1508N | Height 8 mm | In distribution |
| CT1507 | Height 7 mm | In distribution |
| CT1710 | Height 10 mm | In distribution |
| CT1505-0 | Length 15 mm | In distribution |
| 179-040-002 | In distribution | |
| 1709N | Length 17 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 |
|---|---|
| K123206 | 2013-02-07 |
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.