Spinenet ACC®
SpineNet ACC® Inserter Assembly-Instrument
7manufacturers in China registered for this device type
28catalogue numbers in this listing
1510(k) clearance
1recall
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 | SpineNet LLC, 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, Manufacturer |
| 510(k) | K110733 |
| Record published | 2015-10-05 |
| 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 | Width 12 to 14 mm; length 10 to 12 mm; height 5 to 10 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CL101210 | Height 10 mm | In distribution |
| CTL121409 | Height 9 mm | In distribution |
| CINS1100 | In distribution | |
| CTRC1400 | In distribution | |
| CL121407 | Height 7 mm | In distribution |
| CTL121410 | Height 10 mm | In distribution |
| CL101206 | Height 6 mm | In distribution |
| CTL101207 | Height 7 mm | In distribution |
| CL121410 | Height 10 mm | In distribution |
| CTL101209 | Height 9 mm | In distribution |
| CTL121407 | Height 7 mm | In distribution |
| CTL101208 | Height 8 mm | In distribution |
| CGRB1200 | In distribution | |
| CL121408 | Height 8 mm | In distribution |
| CL101205 | Height 5 mm | In distribution |
| CL101208 | In distribution | |
| CTL121408 | Height 8 mm | In distribution |
| CTL101205 | Height 5 mm | In distribution |
| CL101209 | Height 9 mm | In distribution |
| CGRP1300 | In distribution | |
| CTL101210 | Height 10 mm | In distribution |
| CTL101206 | Width 12 mm | In distribution |
| CL121406 | Height 6 mm | In distribution |
| CTL121405 | Height 5 mm | In distribution |
| CTL121406 | Height 6 mm | In distribution |
| CL101207 | Height 7 mm | In distribution |
| CL121409 | Height 9 mm | In distribution |
| CL121405 | Height 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 |
|---|---|
| K110733 | 2011-08-25 |
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 |
|---|---|---|---|---|---|---|---|
| SpineNet LLC | 510(k) number | 2013-02-05 | Class II | Error in labeling | The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing. | 400 | 2014-05-02 |
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.