Zavation Sizer
16X14 Sizer. 10 deg. 11 & 12 mm
7manufacturers in China registered for this device type
102catalogue numbers in this listing
1510(k) clearance
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 | Zavation, 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 | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K162496 |
| Record published | 2026-05-15 |
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, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 29-141210-11 | In distribution | |
| 29-161406-07 | In distribution | |
| 29-181606-07 | In distribution | |
| 29-181606-11 | In distribution | |
| 29-181600-09 | In distribution | |
| 29-161410-11 | In distribution | |
| 29-151300-10 | In distribution | |
| 29-181610-06 | In distribution | |
| 29-151310-09 | In distribution | |
| 29-181610-09 | In distribution | |
| 29-181610-08 | In distribution | |
| 29-151300-08 | In distribution | |
| 29-151300-07 | In distribution | |
| 29-141210-10 | In distribution | |
| 29-151300-11 | In distribution | |
| 29-181600-05 | In distribution | |
| 29-141206-07 | In distribution | |
| 29-181610-12 | In distribution | |
| 29-181606-10 | In distribution | |
| 29-161406-09 | In distribution | |
| 29-161400-09 | In distribution | |
| 29-151306-08 | In distribution | |
| 29-151310-12 | In distribution | |
| 29-181606-05 | In distribution | |
| 29-181606-06 | In distribution | |
| 29-141210-08 | In distribution | |
| 29-151300-05 | In distribution | |
| 29-161400-08 | In distribution | |
| 29-181610-07 | In distribution | |
| 29-181600-12 | In distribution | |
| 29-141210-07 | In distribution | |
| 29-141200-12 | In distribution | |
| 29-161410-08 | In distribution | |
| 29-151306-07 | In distribution | |
| 29-161406-10 | In distribution | |
| 29-161400-11 | In distribution | |
| 29-151310-06 | In distribution | |
| 29-141210-06 | In distribution | |
| 29-141210-09 | In distribution | |
| 29-181600-10 | In distribution | |
| 29-141206-08 | In distribution | |
| ZAV-1255-04 | In distribution | |
| 29-161406-12 | In distribution | |
| 29-151310-11 | In distribution | |
| 29-151306-10 | In distribution | |
| 29-141210-05 | In distribution | |
| 29-161410-05 | In distribution | |
| ZAV-1255-03 | In distribution | |
| 29-141200-11 | In distribution | |
| 29-181606-12 | In distribution | |
| 29-141200-05 | In distribution | |
| 29-161406-06 | In distribution | |
| 29-141200-06 | In distribution | |
| 29-151306-05 | In distribution | |
| 29-151310-10 | In distribution | |
| 29-161410-07 | In distribution | |
| 29-181610-11 | In distribution | |
| 29-141200-07 | In distribution | |
| 29-161400-12 | In distribution | |
| 29-181610-10 | In distribution | |
| 29-161410-10 | In distribution | |
| 29-161406-11 | In distribution | |
| 29-141200-10 | In distribution | |
| 29-151300-12 | In distribution | |
| ZAV-1255-08 | In distribution | |
| 29-141206-12 | In distribution | |
| 29-161400-07 | In distribution | |
| 29-141206-09 | In distribution | |
| ZAV-1255-01 | In distribution | |
| 29-151306-11 | In distribution | |
| 29-151300-06 | In distribution | |
| 29-181610-05 | In distribution | |
| 29-151306-12 | In distribution | |
| 29-141206-05 | In distribution | |
| 29-181606-08 | In distribution | |
| 29-151310-08 | In distribution | |
| 29-181600-06 | In distribution | |
| 29-141206-10 | In distribution | |
| ZAV-1255-02 | In distribution | |
| 29-161410-06 | In distribution | |
| 29-181600-08 | In distribution | |
| 29-141206-06 | In distribution | |
| 29-161406-08 | In distribution | |
| 29-161400-10 | In distribution | |
| 29-151300-09 | In distribution | |
| 29-141206-11 | In distribution | |
| 29-151306-09 | In distribution | |
| 29-161400-05 | In distribution | |
| 29-181606-09 | In distribution | |
| 29-141200-09 | In distribution | |
| 29-141200-08 | In distribution | |
| 29-181600-07 | In distribution | |
| 29-151310-05 | In distribution | |
| 29-161400-06 | In distribution | |
| ZAV-1255-12 | In distribution | |
| 29-141210-12 | In distribution | |
| 29-161406-05 | In distribution | |
| 29-161410-12 | In distribution | |
| 29-181600-11 | In distribution | |
| 29-151306-06 | In distribution | |
| 29-151310-07 | In distribution | |
| 29-161410-09 | 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 |
|---|---|
| K112664 | 2011-12-23 |
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.