A-Cift
A-CIFT SoloFuse PEEK IBFD, 16Lx19W, 18°, 10MM, HA PEEK
5manufacturers in China registered for this device type
254catalogue 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 | 2020-07-10 |
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 13.5 to 16 mm; width 17 to 19 mm; angle 6 to 18 °; height 5 to 12 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-32119-1406 | Length 13.5 mm | In distribution |
| 01-32021-1009-HA | Angle 10 ° | In distribution |
| 01-32024-1812-PE | Length 16 mm | In distribution |
| 14-32119-1807 | Length 13.5 mm | In distribution |
| 01-32021-1008-PE | Width 17 mm | In distribution |
| 01-32024-0612-HA | Height 12 mm | In distribution |
| 01-32024-1810-HA | Width 19 mm | In distribution |
| 01-32025-1412-HA | Length 13.5 mm | In distribution |
| 01-32025-1005-HA | Angle 10 ° | In distribution |
| 14-32121-1810 | Angle 18 ° | In distribution |
| 01-32021-0609-PE | Height 9 mm | In distribution |
| 01-32021-0608-PE | Angle 6 ° | In distribution |
| 14-32117-02 | In distribution | |
| 01-32021-1006-HA | Width 17 mm | In distribution |
| 01-32021-1011-PE | Height 11 mm | In distribution |
| 01-32025-1008-HA | Length 13.5 mm | In distribution |
| 01-32024-0608-PE | Height 8 mm | In distribution |
| 01-32025-0610-PE | Length 13.5 mm | In distribution |
| 01-32025-1410-PE | Length 13.5 mm | In distribution |
| 01-32021-1012-HA | Height 12 mm | In distribution |
| 01-32021-0611-PE | Length 13.5 mm | In distribution |
| 01-32021-1409-HA | Width 17 mm | In distribution |
| 01-32021-1808-PE | Height 8 mm | In distribution |
| 01-32024-0610-PE | Height 10 mm | In distribution |
| 14-32121-1011 | Angle 10 ° | In distribution |
| 01-32021-1807-HA | Width 17 mm | In distribution |
| 01-32021-1811-PE | Height 11 mm | In distribution |
| 01-32025-1811-HA | Angle 18 ° | In distribution |
| 14-32119-1411 | Height 11 mm | In distribution |
| 01-32024-1410-HA | Height 10 mm | In distribution |
| 14-32120-1809 | Width 19 mm | In distribution |
| 01-32021-1010-HA | Angle 10 ° | In distribution |
| 01-32021-1408-PE | Angle 14 ° | In distribution |
| 01-32025-1408-HA | Length 13.5 mm | In distribution |
| 14-32121-1411 | Width 19 mm | In distribution |
| 01-32021-0607-HA | Angle 6 ° | In distribution |
| 14-32120-1412 | Length 16 mm | In distribution |
| 14-32120-1408 | Length 16 mm | In distribution |
| 01-32025-1006-PE | Angle 10 ° | In distribution |
| 01-32021-1008-HA | Height 8 mm | In distribution |
| 01-32024-1410-PE | Height 10 mm | In distribution |
| 01-32021-1005-HA | Length 13.5 mm | In distribution |
| 14-32119-1809 | Angle 18 ° | In distribution |
| 01-32024-0609-PE | Angle 6 ° | In distribution |
| 01-32021-0606-PE | Width 17 mm | In distribution |
| 01-32025-1812-HA | Width 19 mm | In distribution |
| 14-32120-0607 | Height 7 mm | In distribution |
| 01-32021-0612-PE | Height 12 mm | In distribution |
| 14-32120-1008 | Width 19 mm | In distribution |
| 01-32021-1406-HA | Length 13.5 mm | In distribution |
| 01-32025-0606-PE | Length 13.5 mm | In distribution |
| 01-32021-1012-PE | Angle 10 ° | In distribution |
| 01-32025-0608-HA | Width 19 mm | In distribution |
| 01-32025-1010-HA | Height 10 mm | In distribution |
| 01-32025-1009-HA | Width 19 mm | In distribution |
| 01-32025-1809-PE | Length 13.5 mm | In distribution |
| 01-32025-1808-PE | Angle 18 ° | In distribution |
| 01-32021-0605-HA | Length 13.5 mm | In distribution |
| 01-32024-1411-PE | Height 11 mm | In distribution |
| 01-32021-0608-HA | Length 13.5 mm | In distribution |
| 14-32120-1808 | Angle 18 ° | In distribution |
| 01-32024-1008-PE | Height 8 mm | In distribution |
| 01-32021-1006-PE | Height 6 mm | In distribution |
| 01-32025-1406-HA | Width 19 mm | In distribution |
| 14-32119-0605 | Length 13.5 mm | In distribution |
| 01-32024-1407-HA | Height 7 mm | In distribution |
| 01-32024-0611-HA | Height 11 mm | In distribution |
| 01-32024-0612-PE | Length 16 mm | In distribution |
| 01-32025-0607-HA | Height 7 mm | In distribution |
| 01-32024-1009-PE | Length 16 mm | In distribution |
| 14-32119-0609 | Angle 6 ° | In distribution |
| 14-32120-0608 | Length 16 mm | In distribution |
| 01-32021-0607-PE | Width 17 mm | In distribution |
| 14-32120-1810 | Angle 18 ° | In distribution |
| 01-32021-0612-HA | Length 13.5 mm | In distribution |
| 01-32025-1006-HA | Width 19 mm | In distribution |
| 01-32025-1011-PE | Width 19 mm | In distribution |
| 14-32120-1010 | Width 19 mm | In distribution |
| 14-32121-1410 | Width 19 mm | In distribution |
| 14-32121-0611 | Length 13.5 mm | In distribution |
| 01-32025-1007-HA | Height 7 mm | In distribution |
| 01-32024-1411-HA | Width 19 mm | In distribution |
| 01-32025-1011-HA | Height 11 mm | In distribution |
| 01-32024-1010-HA | Angle 10 ° | In distribution |
| 14-32121-1809 | Angle 18 ° | In distribution |
| 01-32021-1407-PE | Height 7 mm | In distribution |
| 14-32120-1812 | Height 12 mm | In distribution |
| 01-32021-0610-HA | Width 17 mm | In distribution |
| 01-32024-0608-HA | Angle 6 ° | In distribution |
| 01-32025-0612-PE | Length 13.5 mm | In distribution |
| 14-32119-1808 | Width 17 mm | In distribution |
| 01-32025-1812-PE | Angle 18 ° | In distribution |
| 01-32021-1406-PE | Length 13.5 mm | In distribution |
| 01-32025-1807-HA | Width 19 mm | In distribution |
| 14-32120-0610 | Height 10 mm | In distribution |
| 14-32121-1006 | Length 13.5 mm | In distribution |
| 01-32021-1410-PE | Angle 14 ° | In distribution |
| 14-32120-1811 | Length 16 mm | In distribution |
| 01-32025-0607-PE | Angle 6 ° | In distribution |
| 01-32025-0609-HA | Length 13.5 mm | In distribution |
| 01-32024-1007-HA | Height 7 mm | In distribution |
| 14-32121-0607 | Width 19 mm | In distribution |
| 01-32025-1407-HA | Angle 14 ° | In distribution |
| 14-32120-1407 | Height 7 mm | In distribution |
| 01-32024-1407-PE | Width 19 mm | In distribution |
| 01-32024-1409-HA | Length 16 mm | In distribution |
| 01-32024-1408-HA | Width 19 mm | In distribution |
| 01-32025-0610-HA | Height 10 mm | In distribution |
| 01-32025-1406-PE | Width 19 mm | In distribution |
| 14-32120-1409 | Length 16 mm | In distribution |
| 01-32024-1808-HA | Width 19 mm | In distribution |
| 01-32021-0610-PE | Height 10 mm | In distribution |
| 14-32119-1005 | Width 17 mm | In distribution |
| 14-32120-1007 | Length 16 mm | In distribution |
| 01-32025-0605-PE | Height 5 mm | In distribution |
| 14-32121-0608 | Width 19 mm | In distribution |
| 01-32024-1811-PE | Width 19 mm | In distribution |
| 01-32025-0611-PE | Height 11 mm | In distribution |
| 01-32021-1809-HA | Height 9 mm | In distribution |
| 01-32021-1005-PE | Length 13.5 mm | In distribution |
| 14-32120-1009 | Angle 10 ° | In distribution |
| 01-32024-0610-HA | Height 10 mm | In distribution |
| 01-32025-1407-PE | Length 13.5 mm | In distribution |
| 01-32021-1810-PE | Height 10 mm | In distribution |
| 14-32119-1412 | Length 13.5 mm | In distribution |
| 01-32024-1412-HA | Length 16 mm | In distribution |
| 01-32021-1412-HA | Angle 14 ° | In distribution |
| 14-32121-1009 | Width 19 mm | In distribution |
| 14-32119-0607 | Width 17 mm | In distribution |
| 01-32025-0608-PE | Width 19 mm | In distribution |
| 01-32024-0611-PE | Height 11 mm | In distribution |
| 01-32021-1408-HA | Length 13.5 mm | In distribution |
| 01-32025-0612-HA | Angle 6 ° | In distribution |
| 01-32025-1008-PE | Width 19 mm | In distribution |
| 14-32121-1010 | Length 13.5 mm | In distribution |
| 01-32025-1010-PE | Length 13.5 mm | In distribution |
| 01-32024-1808-PE | Width 19 mm | In distribution |
| 01-32025-1012-PE | Length 13.5 mm | In distribution |
| 01-32024-1810-PE | Length 16 mm | In distribution |
| 14-32119-1408 | Length 13.5 mm | In distribution |
| 14-32121-1409 | Length 13.5 mm | In distribution |
| 01-32025-1410-HA | Height 10 mm | In distribution |
| 01-32024-1412-PE | Width 19 mm | In distribution |
| 01-32024-1011-PE | Angle 10 ° | In distribution |
| 14-32121-1811 | Height 11 mm | In distribution |
| 01-32021-1011-HA | Width 17 mm | In distribution |
| 01-32025-1009-PE | Height 9 mm | In distribution |
| 01-32021-1411-PE | Length 13.5 mm | In distribution |
| 14-32121-1007 | Height 7 mm | In distribution |
| 01-32025-1811-PE | Width 19 mm | In distribution |
| 14-32120-0605 | Angle 6 ° | In distribution |
| 01-32025-1810-PE | Length 13.5 mm | In distribution |
| 01-32025-1409-PE | Width 19 mm | In distribution |
| 01-32021-1410-HA | Angle 14 ° | In distribution |
| 14-32121-1005 | Height 5 mm | In distribution |
| 01-32024-0605-PE | Length 16 mm | In distribution |
| 14-32119-1010 | Height 10 mm | In distribution |
| 01-32021-0609-HA | Length 13.5 mm | In distribution |
| 14-32120-1011 | Width 19 mm | In distribution |
| 01-32025-0606-HA | Height 6 mm | In distribution |
| 14-32119-1409 | Height 9 mm | In distribution |
| 01-32021-1007-HA | Height 7 mm | In distribution |
| 14-32121-1407 | Width 19 mm | In distribution |
| 14-32121-1406 | Height 5 mm | In distribution |
| 01-32021-1010-PE | Length 13.5 mm | In distribution |
| 14-32119-1012 | Width 17 mm | In distribution |
| 01-32021-1009-PE | Height 9 mm | In distribution |
| 01-32021-1811-HA | Length 13.5 mm | In distribution |
| 14-32117-01 | In distribution | |
| 01-32025-0611-HA | Width 19 mm | In distribution |
| 14-32119-1006 | Height 6 mm | In distribution |
| 01-32024-0607-HA | Length 16 mm | In distribution |
| 01-32024-1809-PE | Length 16 mm | In distribution |
| 14-32121-1008 | Width 19 mm | In distribution |
| 14-32119-1407 | Height 7 mm | In distribution |
| 01-32024-1008-HA | Length 16 mm | In distribution |
| 01-32021-1812-PE | Length 13.5 mm | In distribution |
| 14-32119-1011 | Width 17 mm | In distribution |
| 14-32120-0611 | Length 16 mm | In distribution |
| 14-32120-0612 | Width 19 mm | In distribution |
| 14-32121-0610 | Angle 6 ° | In distribution |
| 14-32119-1007 | Angle 10 ° | In distribution |
| 14-32119-0606 | Height 6 mm | In distribution |
| 14-32120-1410 | Angle 14 ° | In distribution |
| 01-32025-1412-PE | Length 13.5 mm | In distribution |
| 01-32021-1407-HA | Length 13.5 mm | In distribution |
| 01-32025-1807-PE | Height 7 mm | In distribution |
| 14-32121-1412 | Width 19 mm | In distribution |
| 01-32025-1409-HA | Length 13.5 mm | In distribution |
| 01-32025-1411-HA | Height 11 mm | In distribution |
| 01-32025-1411-PE | Width 19 mm | In distribution |
| 14-32121-1408 | Length 13.5 mm | In distribution |
| 01-32021-1409-PE | Length 13.5 mm | In distribution |
| 01-32021-0606-HA | Length 13.5 mm | In distribution |
| 14-32119-1812 | Width 17 mm | In distribution |
| 14-32119-1410 | Height 10 mm | In distribution |
| 01-32024-1006-PE | Length 16 mm | In distribution |
| 01-32024-1811-HA | Length 16 mm | In distribution |
| 01-32025-0605-HA | Angle 6 ° | In distribution |
| 14-32119-0608 | Height 8 mm | In distribution |
| 14-32119-1008 | Angle 10 ° | In distribution |
| 01-32021-1807-PE | Length 13.5 mm | In distribution |
| 14-32121-1812 | Angle 18 ° | In distribution |
| 01-32024-1408-PE | Angle 14 ° | In distribution |
| 14-32121-1808 | Length 13.5 mm | In distribution |
| 14-32121-0609 | Width 19 mm | In distribution |
| 01-32021-1808-HA | Width 17 mm | In distribution |
| 01-32025-1408-PE | Angle 14 ° | In distribution |
| 14-32119-0612 | Height 12 mm | In distribution |
| 01-32025-1007-PE | Length 13.5 mm | In distribution |
| 01-32024-1009-HA | Length 16 mm | In distribution |
| 01-32024-0607-PE | Width 19 mm | In distribution |
| 01-32024-1409-PE | Width 19 mm | In distribution |
| 01-32025-1808-HA | Length 13.5 mm | In distribution |
| 01-32024-1006-HA | Length 16 mm | In distribution |
| 01-32021-1007-PE | Width 17 mm | In distribution |
| 14-32121-0606 | Angle 6 ° | In distribution |
| 01-32024-1012-PE | Length 16 mm | In distribution |
| 14-32121-0605 | Angle 6 ° | In distribution |
| 01-32024-1812-HA | Length 16 mm | In distribution |
| 01-32021-1810-HA | Width 17 mm | In distribution |
| 01-32024-1007-PE | Width 19 mm | In distribution |
| 14-32119-1810 | Angle 18 ° | In distribution |
| 14-32121-0612 | Length 13.5 mm | In distribution |
| 14-32119-0611 | Length 13.5 mm | In distribution |
| 14-32120-0606 | Width 19 mm | In distribution |
| 01-32025-1810-HA | Length 13.5 mm | In distribution |
| 01-32021-1411-HA | Height 11 mm | In distribution |
| 14-32121-1807 | Angle 18 ° | In distribution |
| 14-32119-1009 | Length 13.5 mm | In distribution |
| 14-32120-0609 | Height 9 mm | In distribution |
| 01-32021-1809-PE | Length 13.5 mm | In distribution |
| 14-32121-1012 | Width 19 mm | In distribution |
| 14-32119-1811 | Height 11 mm | In distribution |
| 01-32024-0606-PE | Width 19 mm | In distribution |
| 01-32025-1005-PE | Height 5 mm | In distribution |
| 01-32024-1809-HA | Length 16 mm | In distribution |
| 14-32120-1411 | Length 16 mm | In distribution |
| 01-32025-1012-HA | Height 12 mm | In distribution |
| 01-32025-1809-HA | Height 9 mm | In distribution |
| 01-32021-1412-PE | Angle 14 ° | In distribution |
| 14-32120-1012 | Height 12 mm | In distribution |
| 01-32021-0611-HA | Length 13.5 mm | In distribution |
| 01-32024-0609-HA | Length 16 mm | In distribution |
| 14-32120-1006 | Width 19 mm | In distribution |
| 01-32024-0606-HA | Height 6 mm | In distribution |
| 01-32024-1010-PE | Length 16 mm | In distribution |
| 01-32025-0609-PE | Height 9 mm | In distribution |
| 01-32021-1812-HA | Height 12 mm | In distribution |
| 01-32021-0605-PE | Height 5 mm | In distribution |
Showing 250 of 254 catalogue numbers.
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 |
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.