Zavation
Cervical Interbody, 10 deg, 14mm x 12mm - 10mm
5manufacturers in China registered for this device type
423catalogue numbers in this listing
1510(k) clearance
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 | Zavation, 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, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K221049 |
| Record published | 2022-10-10 |
| Record revised | 2025-11-20 (version 5) |
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 | Length 16 mm; outer diameter 4 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 690-101412-10 | In distribution | |
| 690-061614-12 | In distribution | |
| 170-0012 | In distribution | |
| 170-0812 | In distribution | |
| 690-091513-12 | In distribution | |
| 690-15-12 | In distribution | |
| 695-4514 | In distribution | |
| 690-071614-07 | In distribution | |
| 695-4012 | In distribution | |
| 690-051513-08 | In distribution | |
| 170-2000-05 | In distribution | |
| 171-2001-06 | In distribution | |
| 170-10 | In distribution | |
| 691-14-07 | In distribution | |
| 170-0707 | In distribution | |
| 690-001412-10 | In distribution | |
| 691-15-06 | In distribution | |
| 170-0011 | In distribution | |
| 171-0611 | In distribution | |
| 170-07 | In distribution | |
| 690-16-11 | In distribution | |
| 171-2000-12 | In distribution | |
| 694-4518 | In distribution | |
| 690-081412-08 | In distribution | |
| 693-4016 | Length 16 mm | In distribution |
| 690-061614-09 | In distribution | |
| 171-0808 | In distribution | |
| 695-4016 | In distribution | |
| 171-0009 | In distribution | |
| 171-0006 | In distribution | |
| ZAV-1342-01 | In distribution | |
| 171-0007 | In distribution | |
| 690-091513-11 | In distribution | |
| 690-001614-07 | In distribution | |
| 693-4518 | In distribution | |
| 690-001513-07 | In distribution | |
| 170-0612 | In distribution | |
| 690-051614-07 | In distribution | |
| 170-2000-12 | In distribution | |
| 694-4012 | In distribution | |
| 171-1008 | In distribution | |
| 693-4516 | In distribution | |
| 171-2000-10 | In distribution | |
| 690-061412-07 | In distribution | |
| 690-101412-12 | In distribution | |
| 171-2000-07 | In distribution | |
| 690-091412-09 | In distribution | |
| 170-2000-06 | In distribution | |
| 170-0910 | In distribution | |
| 690-081614-07 | In distribution | |
| 690-091513-10 | In distribution | |
| 170-2000-10 | In distribution | |
| 690-001412-12 | In distribution | |
| 690-071513-07 | In distribution | |
| 171-0710 | In distribution | |
| 170-0807 | In distribution | |
| 690-051614-08 | In distribution | |
| 690-101412-06 | In distribution | |
| 171-2001-09 | In distribution | |
| 690-061614-11 | In distribution | |
| 696-4014 | In distribution | |
| 690-1003-12 | In distribution | |
| 690-081412-10 | In distribution | |
| 690-081412-07 | In distribution | |
| 690-14-07 | In distribution | |
| 690-061513-11 | In distribution | |
| 171-0810 | In distribution | |
| 690-001614-10 | In distribution | |
| 690-071513-06 | In distribution | |
| 171-0806 | In distribution | |
| 690-061412-11 | In distribution | |
| 171-0707 | In distribution | |
| 690-071614-06 | In distribution | |
| 690-061513-06 | In distribution | |
| 171-0807 | In distribution | |
| ZAV-1342-08 | In distribution | |
| 690-071513-11 | In distribution | |
| 695-4018 | In distribution | |
| 693-4514 | In distribution | |
| 690-15-06 | In distribution | |
| 171-0906 | In distribution | |
| 171-0708 | In distribution | |
| 170-2000-02 | In distribution | |
| 690-1000-12 | In distribution | |
| 690-061412-08 | In distribution | |
| 171-0609 | In distribution | |
| 696-4020 | In distribution | |
| 170-12 | In distribution | |
| 690-14-08 | In distribution | |
| 690-091513-06 | In distribution | |
| 690-1004 | In distribution | |
| 170-0606 | In distribution | |
| 690-001412-11 | In distribution | |
| 171-0512 | In distribution | |
| ZAV-1338-9 | In distribution | |
| 170-2003 | In distribution | |
| 690-051614-09 | In distribution | |
| 690-061412-06 | In distribution | |
| 690-061614-06 | In distribution | |
| 690-091614-10 | In distribution | |
| 170-0906 | In distribution | |
| ZAV-1338-6 | In distribution | |
| 695-4520 | In distribution | |
| 690-051513-06 | In distribution | |
| 690-081614-12 | In distribution | |
| 170-2000-04 | In distribution | |
| 690-071513-12 | In distribution | |
| 170-0608 | In distribution | |
| 170-0806 | In distribution | |
| 690-1101 | In distribution | |
| 171-0809 | In distribution | |
| 690-091412-07 | In distribution | |
| 171-1010 | In distribution | |
| 170-0610 | In distribution | |
| 690-051412-08 | In distribution | |
| 170-0709 | In distribution | |
| 690-071614-08 | In distribution | |
| 690-15-07 | In distribution | |
| 171-0612 | In distribution | |
| 690-15-10 | In distribution | |
| ZAV-1338-7 | In distribution | |
| 690-051614-06 | In distribution | |
| 170-0511 | In distribution | |
| 690-061513-08 | In distribution | |
| 691-16-07 | In distribution | |
| 690-1002 | In distribution | |
| 171-0709 | In distribution | |
| 694-4514 | In distribution | |
| 690-16-08 | In distribution | |
| 690-101614-07 | In distribution | |
| 690-001513-12 | In distribution | |
| 170-9000 | In distribution | |
| 170-0908 | In distribution | |
| 171-0506 | In distribution | |
| 690-1003-14 | In distribution | |
| 170-0808 | In distribution | |
| 171-0912 | In distribution | |
| 690-14-11 | In distribution | |
| 690-1009 | In distribution | |
| 170-1010 | In distribution | |
| 170-0907 | In distribution | |
| 690-1010-2 | In distribution | |
| 690-091614-06 | In distribution | |
| 171-0610 | In distribution | |
| 690-051513-11 | In distribution | |
| 170-0811 | In distribution | |
| 690-16-10 | In distribution | |
| 170-2000-03 | In distribution | |
| 170-2000-08 | In distribution | |
| 171-0812 | In distribution | |
| 170-0509 | In distribution | |
| 694-4520 | In distribution | |
| 690-001412-09 | In distribution | |
| 171-2000-05 | In distribution | |
| 690-1000-09 | In distribution | |
| 170-0609 | In distribution | |
| 171-2001-07 | In distribution | |
| 690-001614-11 | In distribution | |
| 690-081412-11 | In distribution | |
| 690-1007 | In distribution | |
| 171-2000-09 | In distribution | |
| 170-0607 | In distribution | |
| 690-1000-3 | In distribution | |
| 170-0506 | In distribution | |
| 690-081513-09 | In distribution | |
| 690-001614-12 | In distribution | |
| 690-001513-11 | In distribution | |
| 690-1006 | In distribution | |
| ZAV-1169 | In distribution | |
| 171-2000-08 | In distribution | |
| 170-1011 | In distribution | |
| 690-9000 | In distribution | |
| 171-2000-03 | In distribution | |
| 690-16-09 | In distribution | |
| 690-061513-10 | In distribution | |
| 170-2000-01 | In distribution | |
| 690-101513-06 | In distribution | |
| 690-001412-08 | In distribution | |
| 690-091412-10 | In distribution | |
| 690-1005 | In distribution | |
| 690-091412-06 | In distribution | |
| 690-001412-06 | In distribution | |
| 690-051412-10 | In distribution | |
| 170-06 | In distribution | |
| 690-101614-09 | In distribution | |
| 170-2011 | In distribution | |
| 693-4520 | In distribution | |
| 171-2001-10 | In distribution | |
| 696-4012 | In distribution | |
| 693-4020 | In distribution | |
| 690-001614-06 | In distribution | |
| 690-1000-11 | In distribution | |
| 696-4512 | In distribution | |
| 171-1011 | In distribution | |
| 690-061412-12 | In distribution | |
| 693-4014 | In distribution | |
| 170-0712 | In distribution | |
| 691-16-09 | In distribution | |
| 690-101614-10 | In distribution | |
| 690-051412-11 | In distribution | |
| 690-101412-11 | In distribution | |
| 690-071513-08 | In distribution | |
| 171-2001-04 | In distribution | |
| 690-001513-09 | In distribution | |
| 695-4014 | In distribution | |
| 691-16-11 | In distribution | |
| 690-091614-12 | In distribution | |
| 690-16-07 | In distribution | |
| 690-081513-06 | In distribution | |
| 690-081513-12 | In distribution | |
| 171-0706 | In distribution | |
| 690-071412-07 | In distribution | |
| 171-0910 | In distribution | |
| 690-1001 | In distribution | |
| 690-101614-08 | In distribution | |
| 170-2012 | In distribution | |
| 690-1008 | In distribution | |
| 695-4020 | In distribution | |
| 690-001412-07 | In distribution | |
| 171-2000-06 | In distribution | |
| 690-061513-07 | In distribution | |
| 691-15-10 | In distribution | |
| 693-4018 | In distribution | |
| 171-1012 | In distribution | |
| 690-071614-10 | In distribution | |
| 690-081614-06 | In distribution | |
| 170-0706 | In distribution | |
| 171-0606 | In distribution | |
| 690-091412-08 | In distribution | |
| 690-101513-10 | In distribution | |
| 691-14-06 | In distribution | |
| 690-051412-06 | In distribution | |
| 690-051412-12 | In distribution | |
| 690-14-06 | In distribution | |
| 690-1003-20 | In distribution | |
| 171-0712 | In distribution | |
| 171-0908 | In distribution | |
| 690-091513-07 | In distribution | |
| 690-15-09 | In distribution | |
| 170-1009 | In distribution | |
| 690-101513-09 | In distribution | |
| 691-15-09 | In distribution | |
| ZAV-1319 | In distribution | |
| 690-061513-12 | In distribution | |
| 171-0811 | In distribution | |
| 171-0711 | In distribution | |
| 691-14-08 | In distribution | |
| 690-081614-11 | In distribution | |
| 690-071412-10 | In distribution | |
| 690-101614-12 | In distribution |
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 |
| 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 |
| A-Cift | Spinefrontier, Inc. | 254 |
Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141005 | 2014-08-07 |
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.