Unison™-C Anterior Cervical Fixation System
Interbody Fusion Device, 20mm (W), 16mm (D), 10mm (H), 7° Lordosis
5manufacturers in China registered for this device type
334catalogue numbers in this listing
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 | Pioneer Surgical Technology, 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 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Record published | 2016-01-28 |
| Record revised | 2026-02-12 (version 8) |
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 |
| Distribution end date | 2022-12-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 63-40-FSD-15 | Withdrawn | |
| 63-TR-2016-11-7L | Withdrawn | |
| 63-1616-12-7L | Withdrawn | |
| 63-35-VSD-16 | Withdrawn | |
| 63-40-VST-18 | Withdrawn | |
| 63-1614-8-7L | Withdrawn | |
| 63-40-VSD-20 | Withdrawn | |
| 63-TR-1816-12-7L | Withdrawn | |
| 64-2016-10-7L | 20mm (W), 16mm (D), 10mm (H), 7° Lordosis | Withdrawn |
| 64-2216-10-7L | 22mm (W), 16mm (D), 10mm (H), 7° Lordosis | Withdrawn |
| 64-1814-8-0L | 18mm (W), 14mm (D), 8mm (H), 0° Lordosis | Withdrawn |
| 63-TR-1614-8-7L | Withdrawn | |
| 63-1412-8-7L | Withdrawn | |
| 64-2214-6-0L | 22mm (W), 14mm (D), 6mm (H), 0° Lordosis | Withdrawn |
| 64-1816-9-0L | 18mm (W), 16mm (D), 9mm (H), 0° Lordosis | Withdrawn |
| 64-1612-12-0L | 16mm (W), 12mm (D), 12mm (H), 0° Lordosis | Withdrawn |
| 63-1614-11-7L | Withdrawn | |
| 63-TR-1414-7-7L | Withdrawn | |
| 64-1614-9-0L | 16mm (W), 14mm (D), 9mm (H), 0° Lordosis | Withdrawn |
| 64-2214-9-7L | 22mm (W), 14mm (D), 9mm (H), 7° Lordosis | Withdrawn |
| 63-2016-11-7L | Withdrawn | |
| 63-TR-1614-10-7L | Withdrawn | |
| 63-2014-6-7L | Withdrawn | |
| 64-2016-11-7L | 20mm (W), 16mm (D), 11mm (H), 7° Lordosis | Withdrawn |
| 63-2016-12-7L | Withdrawn | |
| 64-2216-12-7L | 22mm (W), 16mm (D), 12mm (H), 7° Lordosis | Withdrawn |
| 63-40-VST-17 | Withdrawn | |
| 63-TR-2016-9-7L | Withdrawn | |
| 63-TR-1816-6-7L | Withdrawn | |
| 63-TR-1616-9-7L | Withdrawn | |
| 63-40-FST-14 | Withdrawn | |
| 63-35-FST-16 | Withdrawn | |
| 63-TR-1616-8-7L | Withdrawn | |
| 63-2016-6-7L | Withdrawn | |
| 63-1614-6-7L | Withdrawn | |
| 64-1816-6-0L | 18mm (W), 16mm (D), 6mm (H), 0° Lordosis | Withdrawn |
| 64-1814-10-0L | 18mm (W), 14mm (D), 10mm (H), 0° Lordosis | Withdrawn |
| 64-39-ST-12 | Ø 3.9mm, 12mm (L) | Withdrawn |
| 64-1612-10-7L | 16mm (W), 12mm (D), 10mm (H), 7° Lordosis | Withdrawn |
| 64-2216-8-0L | 22mm (W), 16mm (D), 8mm (H), 0° Lordosis | Withdrawn |
| 64-2014-7-7L | 20mm (W), 14mm (D), 7mm (H), 7° Lordosis | Withdrawn |
| 63-40-FST-12 | Withdrawn | |
| 64-1614-6-0L | 16mm (W), 14mm (D), 6mm (H), 0° Lordosis | Withdrawn |
| 64-2014-11-7L | 20mm (W), 14mm (D), 11mm (H), 7° Lordosis | Withdrawn |
| 64-2214-6-7L | 22mm (W), 14mm (D), 6mm (H), 7° Lordosis | Withdrawn |
| 63-1414-10-7L | Withdrawn | |
| 63-35-FSD-13 | Withdrawn | |
| 63-INSERTGUIDE-6 | Withdrawn | |
| 63-1414-9-7L | Withdrawn | |
| 63-35-VST-12 | Withdrawn | |
| 63-35-VSD-14 | Withdrawn | |
| 64-1816-8-7L | 18mm (W), 16mm (D), 8mm (H), 7° Lordosis | Withdrawn |
| 63-SCREWDRIVER | Withdrawn | |
| 64-1816-12-7L | 18mm (W), 16mm (D), 12mm (H), 7° Lordosis | Withdrawn |
| 64-2016-11-0L | 20mm (W), 16mm (D), 11mm (H), 0° Lordosis | Withdrawn |
| 63-1814-10-7L | Withdrawn | |
| 63-TR-2016-12-7L | Withdrawn | |
| 63-35-FSD-18 | Withdrawn | |
| 63-1412-7-7L | Withdrawn | |
| 64-2016-6-7L | 20mm (W), 16mm (D), 6mm (H), 7° Lordosis | Withdrawn |
| 63-TR-1816-7-7L | Withdrawn | |
| 63-40-FSD-20 | Withdrawn | |
| 63-40-FST-16 | Withdrawn | |
| 64-1612-8-7L | 16mm (W), 12mm (D), 8mm (H), 7° Lordosis | Withdrawn |
| 63-TR-1816-9-7L | Withdrawn | |
| 63-TR-1412-11-7L | Withdrawn | |
| 63-35-VSD-15 | Withdrawn | |
| 64-2016-7-7L | 20mm (W), 16mm (D), 7mm (H), 7° Lordosis | Withdrawn |
| 64-1816-10-0L | 18mm (W), 16mm (D), 10mm (H), 0° Lordosis | Withdrawn |
| 63-1412-9-7L | Withdrawn | |
| 63-GUIDEDAWL | Withdrawn | |
| 63-TR-1412-9-7L | Withdrawn | |
| 64-2216-12-0L | 22mm (W), 16mm (D), 12mm (H), 0° Lordosis | Withdrawn |
| 63-35-VST-14 | Withdrawn | |
| 63-40-FST-18 | Withdrawn | |
| 63-40-VST-16 | Withdrawn | |
| 63-TR-2014-10-7L | Withdrawn | |
| 63-40-VST-15 | Withdrawn | |
| 63-1414-6-7L | Withdrawn | |
| 63-40-VSD-18 | Withdrawn | |
| 63-TR-1816-10-7L | Withdrawn | |
| 64-34-SD-14 | Ø 3.4mm, 14mm (L) | Withdrawn |
| 63-1414-12-7L | Withdrawn | |
| 63-40-FST-20 | Withdrawn | |
| 63-35-FSD-14 | Withdrawn | |
| 63-TR-1614-12-7L | Withdrawn | |
| 64-2014-10-7L | 20mm (W), 14mm (D), 10mm (H), 7° Lordosis | Withdrawn |
| 63-40-FSD-19 | Withdrawn | |
| 63-1414-8-7L | Withdrawn | |
| 64-2214-7-0L | 22mm (W), 14mm (D), 7mm (H), 0° Lordosis | Withdrawn |
| 63-TR-2014-11-7L | Withdrawn | |
| 64-2014-9-0L | 20mm (W), 14mm (D), 9mm (H), 0° Lordosis | Withdrawn |
| 63-1614-9-7L | Withdrawn | |
| 64-2214-7-7L | 22mm (W), 14mm (D), 7mm (H), 7° Lordosis | Withdrawn |
| 63-35-VSD-19 | Withdrawn | |
| 63-40-FSD-12 | Withdrawn | |
| 63-TR-2016-8-7L | Withdrawn | |
| 64-2216-9-0L | 22mm (W), 16mm (D), 9mm (H), 0° Lordosis | Withdrawn |
| 63-1412-11-7L | Withdrawn | |
| 63-1614-7-7L | Withdrawn | |
| 63-TR-1414-8-7L | Withdrawn | |
| 64-2014-11-0L | 20mm (W), 14mm (D), 11mm (H), 0° Lordosis | Withdrawn |
| 63-HOUSING-6-10 | Withdrawn | |
| 64-1816-9-7L | 18mm (W), 16mm (D), 9mm (H), 7° Lordosis | Withdrawn |
| 63-TR-1814-10-7L | Withdrawn | |
| 64-34-ST-13 | Ø 3.4mm, 13mm (L) | Withdrawn |
| 64-2016-12-7L | 20mm (W), 16mm (D), 12mm (H), 7° Lordosis | Withdrawn |
| 63-1414-7-7L | Withdrawn | |
| 63-40-VST-12 | Withdrawn | |
| 63-TR-1814-11-7L | Withdrawn | |
| 63-40-VST-14 | Withdrawn | |
| 63-TR-1414-12-7L | Withdrawn | |
| 64-2014-6-0L | 20mm (W), 14mm (D), 6mm (H), 0° Lordosis | Withdrawn |
| 64-34-SD-16 | Ø 3.4mm, 16mm (L) | Withdrawn |
| 63-35-FSD-12 | Withdrawn | |
| 64-34-ST-12 | Ø 3.4mm, 12mm (L) | Withdrawn |
| 63-1616-9-7L | Withdrawn | |
| 63-PACKERBLOCK | Withdrawn | |
| 64-2214-9-0L | 22mm (W), 14mm (D), 9mm (H), 0° Lordosis | Withdrawn |
| 63-35-VSD-13 | Withdrawn | |
| 63-TR-1414-9-7L | Withdrawn | |
| 63-40-VSD-15 | Withdrawn | |
| 63-TR-1616-11-7L | Withdrawn | |
| 64-2214-11-7L | 22mm (W), 16mm (D), 11mm (H), 7° Lordosis | Withdrawn |
| 63-2014-8-7L | Withdrawn | |
| 63-TR-1614-11-7L | Withdrawn | |
| 63-ANG-HANDLE | Withdrawn | |
| 63-1814-8-7L | Withdrawn | |
| 63-TR-1616-10-7L | Withdrawn | |
| 64-1816-11-0L | 18mm (W), 16mm (D), 11mm (H), 0° Lordosis | Withdrawn |
| 63-2014-11-7L | Withdrawn | |
| 64-39-ST-16 | Ø 3.9mm, 16mm (L) | Withdrawn |
| 63-35-FST-18 | Withdrawn | |
| 64-39-ST-13 | Ø 3.9mm, 13mm (L) | Withdrawn |
| 64-2216-11-7L | 22mm (W), 16mm (D), 11mm (H), 7° Lordosis | Withdrawn |
| 63-40-FSD-16 | Withdrawn | |
| 63-35-VST-13 | Withdrawn | |
| 64-1612-8-0L | 16mm (W), 12mm (D), 8mm (H), 0° Lordosis | Withdrawn |
| 63-TR-2016-10-7L | Withdrawn | |
| 63-40-VSD-13 | Withdrawn | |
| 63-TR-1814-12-7L | Withdrawn | |
| 63-1814-6-7L | Withdrawn | |
| 63-35-VSD-18 | Withdrawn | |
| 63-1814-11-7L | Withdrawn | |
| 64-1614-11-0L | 16mm (W), 14mm (D), 11mm (H), 0° Lordosis | Withdrawn |
| 63-TR-1614-9-7L | Withdrawn | |
| 63-TR-1814-7-7L | Withdrawn | |
| 63-1616-7-7L | Withdrawn | |
| 64-1816-7-7L | 18mm (W), 16mm (D), 7mm (H), 7° Lordosis | Withdrawn |
| 64-2216-7-7L | 22mm (W), 16mm (D), 7mm (H), 7° Lordosis | Withdrawn |
| 63-40-VST-19 | Withdrawn | |
| 63-TR-2016-6-7L | Withdrawn | |
| 63-TR-1412-7-7L | Withdrawn | |
| 64-1816-10-7L | 18mm (W), 16mm (D), 10mm (H), 7° Lordosis | Withdrawn |
| 63-TR-2014-9-7L | Withdrawn | |
| 63-1816-7-7L | Withdrawn | |
| 64-1614-8-7L | 16mm (W), 14mm (D), 8mm (H), 7° Lordosis | Withdrawn |
| 63-TR-1412-12-7L | Withdrawn | |
| 63-1412-12-7L | Withdrawn | |
| 63-TR-1414-10-7L | Withdrawn | |
| 63-INSERTGUIDE-9 | Withdrawn | |
| 64-1614-8-0L | 16mm (W), 14mm (D), 8mm (H), 0° Lordosis | Withdrawn |
| 64-1612-9-0L | 16mm (W), 12mm (D), 9mm (H), 0° Lordosis | Withdrawn |
| 64-1612-12-7L | 16mm (W), 12mm (D), 12mm (H), 7° Lordosis | Withdrawn |
| 63-INSERTGUIDE-11 | Withdrawn | |
| 63-40-VST-13 | Withdrawn | |
| 64-2016-8-7L | 20mm (W), 16mm (D), 8mm (H), 7° Lordosis | Withdrawn |
| 63-2014-9-7L | Withdrawn | |
| 63-35-FSD-17 | Withdrawn | |
| 64-2014-10-0L | 20mm (W), 14mm (D), 10mm (H), 0° Lordosis | Withdrawn |
| 63-1814-12-7L | Withdrawn | |
| 63-35-VST-15 | Withdrawn | |
| 64-1612-7-7L | 16mm (W), 12mm (D), 7mm (H), 7° Lordosis | Withdrawn |
| 63-40-FSD-17 | Withdrawn | |
| 63-ANG-SCREWDRIVER | Withdrawn | |
| 63-40-FST-19 | Withdrawn | |
| 63-35-FST-17 | Withdrawn | |
| 63-35-VSD-12 | Withdrawn | |
| 64-1814-9-0L | 18mm (W), 14mm (D), 9mm (H), 0° Lordosis | Withdrawn |
| 63-1816-10-7L | Withdrawn | |
| 64-1814-9-7L | 18mm (W), 14mm (D), 9mm (H), 7° Lordosis | Withdrawn |
| 63-1412-6-7L | Withdrawn | |
| 63-35-FSD-15 | Withdrawn | |
| 64-34-ST-14 | Ø 3.4mm, 14mm (L) | Withdrawn |
| 63-40-FST-15 | Withdrawn | |
| 64-2016-8-0L | 20mm (W), 16mm (D), 8mm (H), 0° Lordosis | Withdrawn |
| 63-TR-1414-6-7L | Withdrawn | |
| 64-2216-9-7L | 22mm (W), 16mm (D), 9mm (H), 7° Lordosis | Withdrawn |
| 64-2216-8-7L | 22mm (W), 16mm (D), 8mm (H), 7° Lordosis | Withdrawn |
| 63-TR-1414-11-7L | Withdrawn | |
| 63-ANG-HOUSING | Withdrawn | |
| 64-39-ST-15 | Ø 3.9mm, 15mm (L) | Withdrawn |
| 63-40-VSD-16 | Withdrawn | |
| 63-TR-1816-8-7L | Withdrawn | |
| 64-34-SD-13 | Ø 3.4mm, 13mm (L) | Withdrawn |
| 64-2214-8-0L | 22mm (W), 14mm (D), 8mm (H), 0° Lordosis | Withdrawn |
| 63-1816-9-7L | Withdrawn | |
| 64-1614-10-7L | 16mm (W), 14mm (D), 10mm (H), 7° Lordosis | Withdrawn |
| 63-1816-8-7L | Withdrawn | |
| 64-1614-7-7L | 16mm (W), 14mm (D), 7mm (H), 7° Lordosis | Withdrawn |
| 64-1614-6-7L | 16mm (W), 14mm (D), 6mm (H), 7° Lordosis | Withdrawn |
| 63-INSERTGUIDE-10 | Withdrawn | |
| 64-1816-7-0L | 18mm (W), 16mm (D), 7mm (H), 0° Lordosis | Withdrawn |
| 63-35-FSD-19 | Withdrawn | |
| 63-35-VST-17 | Withdrawn | |
| 63-TR-1412-10-7L | Withdrawn | |
| 63-35-VST-16 | Withdrawn | |
| 63-40-FSD-18 | Withdrawn | |
| 64-1814-6-7L | 18mm (W), 14mm (D), 6mm (H), 7° Lordosis | Withdrawn |
| 64-1612-7-0L | 16mm (W), 12mm (D), 7mm (H), 0° Lordosis | Withdrawn |
| 63-2016-10-7L | Withdrawn | |
| 64-1612-6-0L | 16mm (W), 12mm (D), 6mm (H), 0° Lordosis | Withdrawn |
| 63-2016-9-7L | Withdrawn | |
| 64-1814-10-7L | 18mm (W), 14mm (D), 10mm (H), 7° Lordosis | Withdrawn |
| 63-TR-1412-6-7L | Withdrawn | |
| 63-TR-2014-12-7L | Withdrawn | |
| 64-2216-7-0L | 22mm (W), 16mm (D), 7mm (H), 0° Lordosis | Withdrawn |
| 63-35-VST-20 | Withdrawn | |
| 63-35-VSD-17 | Withdrawn | |
| 64-2216-11-0L | 22mm (W), 16mm (D), 11mm (H), 0° Lordosis | Withdrawn |
| 63-1816-11-7L | Withdrawn | |
| 63-TR-1614-7-7L | Withdrawn | |
| 63-35-FST-14 | Withdrawn | |
| 63-LOCKER | Withdrawn | |
| 63-1412-10-7L | Withdrawn | |
| 64-2214-10-0L | 22mm (W), 16mm (D), 10mm (H), 0° Lordosis | Withdrawn |
| 64-2016-10-0L | 20mm (W), 16mm (D), 10mm (H), 0° Lordosis | Withdrawn |
| 63-35-VST-19 | Withdrawn | |
| 64-34-SD-15 | Ø 3.4mm, 15mm (L) | Withdrawn |
| 64-2014-7-0L | 20mm (W), 14mm (D), 7mm (H), 0° Lordosis | Withdrawn |
| 63-35-FSD-16 | Withdrawn | |
| 64-2016-9-7L | 20mm (W), 16mm (D), 9mm (H), 7° Lordosis | Withdrawn |
| 63-40-FSD-13 | Withdrawn | |
| 64-1612-11-7L | 16mm (W), 12mm (D), 11mm (H), 7° Lordosis | Withdrawn |
| 63-40-VST-20 | Withdrawn | |
| 63-TR-2014-7-7L | Withdrawn | |
| 64-1814-12-0L | 18mm (W), 14mm (D), 12mm (H), 0° Lordosis | Withdrawn |
| 64-39-ST-14 | Ø 3.9mm, 14mm (L) | Withdrawn |
| 63-TAMP | Withdrawn | |
| 64-2214-10-7L | 22mm (W), 16mm (D), 10mm (H), 7° Lordosis | Withdrawn |
| 64-34-ST-15 | Ø 3.4mm, 15mm (L) | Withdrawn |
| 64-1612-6-7L | 16mm (W), 12mm (D), 6mm (H), 7° Lordosis | Withdrawn |
| 63-35-FST-13 | Withdrawn | |
| 63-1814-7-7L | Withdrawn | |
| 63-40-VSD-14 | Withdrawn | |
| 63-TR-2014-8-7L | Withdrawn | |
| 64-1614-9-7L | 16mm (W), 14mm (D), 9mm (H), 7° Lordosis | Withdrawn |
| 63-TR-1816-11-7L | Withdrawn | |
| 63-1616-8-7L | Withdrawn | |
| 64-34-SD-12 | Ø 3.4mm, 12mm (L) | Withdrawn |
Showing 250 of 300 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 |
| Chesapeake® Stabilization System | VB Spine LLC | 272 |
| UniSpace® Stand-Alone C Cage | CG MedTech Co., Ltd. | 260 |
| Solitaire-C Cervical Spacer | Biomet Spine | 256 |
| A-Cift | Spinefrontier, Inc. | 254 |
Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical
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.