Novel Spinal Spacer System
Novel Cervical Spacer, 10 mm Medium, 7deg Lordotic, PEEK
7manufacturers in China registered for this device type
24catalogue numbers in this listing
4510(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 | Alphatec Spine, 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, Exporter |
| 510(k) | K081730 |
| Record published | 2015-08-31 |
| 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 |
| Sizes | Width 12 to 14 mm; height 5 to 12 mm; length 12 to 16 mm; angle 7 ° |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 64763-106 | Width 12 mm | In distribution |
| 64765-106 | Width 12 mm | In distribution |
| 64763-111 | Length 12 mm | In distribution |
| 64763-107 | Height 7 mm | In distribution |
| 64765-110 | Angle 7 ° | In distribution |
| 64763-112 | Length 12 mm | In distribution |
| 64763-108 | Height 8 mm | In distribution |
| 64763-105 | Width 12 mm | In distribution |
| 64767-112 | Angle 7 ° | In distribution |
| 64765-111 | Width 12 mm | In distribution |
| 64765-108 | Angle 7 ° | In distribution |
| 64765-112 | Angle 7 ° | In distribution |
| 64767-111 | Angle 7 ° | In distribution |
| 64765-109 | Width 12 mm | In distribution |
| 64767-107 | Angle 7 ° | In distribution |
| 64763-110 | Width 12 mm | In distribution |
| 64763-109 | Length 12 mm | In distribution |
| 64767-106 | Angle 7 ° | In distribution |
| 64767-110 | Length 16 mm | In distribution |
| 64767-109 | Angle 7 ° | In distribution |
| 64765-107 | Angle 7 ° | In distribution |
| 64765-105 | Height 5 mm | In distribution |
| 64767-105 | Width 14 mm | In distribution |
| 64767-108 | Angle 7 ° | 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 |
|---|---|
| K251080 | 2025-07-03 |
| K222973 | 2022-11-17 |
| K181435 | 2018-08-21 |
| K081730 | 2008-09-19 |
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.