A-Cift® SoloFuse®
A-CIFT SOLOFUSE IBFD, Lordotic 13mm Long, 17mm Wide, 12mm Height HA PEEK
5manufacturers in China registered for this device type
69catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Spinefrontier, Inc., United States |
|---|---|
| FDA product code | OVE |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K131880 |
| Record published | 2016-04-15 |
| Record revised | 2020-02-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 12 to 16 mm; outer diameter 4.2 to 4.5 mm; width 17 mm; height 5 to 12 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-32009-13 | Length 13 mm | In distribution |
| 01-32009-15 | Length 15 mm | In distribution |
| 01-32020-08-HA | Width 17 mm | In distribution |
| 11-32002-1706 | In distribution | |
| 01-32010-14 | Outer Diameter 4.2 mm | In distribution |
| 01-32017-05 | Width 17 mm | In distribution |
| 01-32017-06 | Length 13 mm | In distribution |
| 01-32017-07 | Length 13 mm | In distribution |
| 11-32106 | In distribution | |
| 11-32114-1707 | In distribution | |
| 11-32001-1710 | In distribution | |
| 11-32002-1708 | In distribution | |
| 11-32114-1711 | In distribution | |
| 11-32114-1709 | In distribution | |
| 01-32020-12-HA | Height 12 mm | In distribution |
| 01-32020-11-HA | Height 11 mm | In distribution |
| 11-32104-08 | In distribution | |
| 01-32017-08 | Length 13 mm | In distribution |
| 11-32002-1711 | In distribution | |
| 01-32010-13 | Outer Diameter 4.2 mm | In distribution |
| 01-32017-11 | Height 11 mm | In distribution |
| 11-32114-1712 | In distribution | |
| 01-32020-10-HA | Width 17 mm | In distribution |
| 11-32114-1706 | In distribution | |
| 01-32010-12 | Outer Diameter 4.2 mm | In distribution |
| 11-32114-1705 | In distribution | |
| 11-32001-1711 | In distribution | |
| 11-32002-1705 | In distribution | |
| 11-32001-1705 | In distribution | |
| 01-32010-15 | Length 15 mm | In distribution |
| 11-32002-1710 | In distribution | |
| 01-32005-14 | Outer Diameter 4.2 mm | In distribution |
| 01-32005-15 | Outer Diameter 4.2 mm | In distribution |
| 11-32104-06 | In distribution | |
| 11-32104-10 | In distribution | |
| 01-32009-16 | Length 16 mm | In distribution |
| 11-32001-1712 | In distribution | |
| 11-32001-1708 | In distribution | |
| 01-32009-12 | Outer Diameter 4.5 mm | In distribution |
| 01-32011-14 | Length 14 mm | In distribution |
| 11-32104-12 | In distribution | |
| 01-32017-09 | Width 17 mm | In distribution |
| 01-32017-12 | Width 17 mm | In distribution |
| 01-32005-13 | Length 13 mm | In distribution |
| 11-32001-1706 | In distribution | |
| 11-32104-07 | In distribution | |
| 01-32020-09-HA | Width 17 mm | In distribution |
| 11-32114-1708 | In distribution | |
| 01-32009-14 | Length 14 mm | In distribution |
| 11-32104-09 | In distribution | |
| 11-32002-1709 | In distribution | |
| 01-32005-12 | Outer Diameter 4.2 mm | In distribution |
| 01-32005-16 | Length 16 mm | In distribution |
| 01-32011-12 | Outer Diameter 4.5 mm | In distribution |
| 11-32114-1710 | In distribution | |
| 11-32001-1709 | In distribution | |
| 01-32017-10 | Length 13 mm | In distribution |
| 11-32113 | In distribution | |
| 11-32103 | In distribution | |
| 11-32002-1712 | In distribution | |
| 11-32001-1707 | In distribution | |
| 11-32002-1707 | In distribution | |
| 11-32104-11 | In distribution | |
| 01-32020-05-HA | Width 17 mm | In distribution |
| 11-32104-05 | In distribution | |
| 01-32020-06-HA | Height 6 mm | In distribution |
| 01-32010-16 | Outer Diameter 4.2 mm | In distribution |
| 11-32105 | In distribution | |
| 01-32020-07-HA | Width 17 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IdentiTi | Alphatec Spine, Inc. | 630 |
| Dolomite | Astura Medical | 607 |
| CoRoent | Nuvasive, Inc. | 580 |
| Aeon-C | Diomedical Co., Ltd. | 508 |
| Tomcat™ Cervical Spinal System | Choice Spine, LP | 468 |
| Shoreline ACS | Seaspine Orthopedics Corporation | 428 |
| Zavation | Zavation | 423 |
| Alta™ Stand-Alone Interbody Fusion System | Biomet Spine | 404 |
| Unison™-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc. | 334 |
| Chesapeake® Stabilization System | VB Spine LLC | 272 |
| UniSpace® Stand-Alone C Cage | CG MedTech Co., Ltd. | 260 |
| Solitaire-C Cervical Spacer | Biomet Spine | 256 |
Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172484 | 2018-05-08 |
| K151198 | 2015-07-17 |
| K131880 | 2014-01-03 |
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 |
|---|---|---|---|---|---|---|---|
| Spinefrontier, Inc. DBA LESspine Innovations | 510(k) number | 2019-06-13 | Class II | Process control | There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw. | 6 | 2020-05-11 |
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.