Zavation Alif Sizer
Alif Sizer
3manufacturers in China registered for this device type
172catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 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 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Zavation, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K230731 |
| Record published | 2025-09-05 |
| Record revised | 2025-11-20 (version 3) |
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, manufacturing date, serial number |
| Distribution end date | 2025-06-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 869-1051-2530-19-R | In distribution | |
| 869-1051-2535-17-S | In distribution | |
| 869-1051-1530-13-R | In distribution | |
| 869-1051-1530-12-R | In distribution | |
| 869-1051-3030-15-S | In distribution | |
| 869-1051-3030-19-S | In distribution | |
| 869-1051-2040-15-S | In distribution | |
| 869-1051-1540-11-R | In distribution | |
| 869-1051-3035-25-S | In distribution | |
| 869-1051-2035-21-S | In distribution | |
| 869-1051-1530-17-R | In distribution | |
| 869-1051-2030-17-S | In distribution | |
| 869-1051-0840-19-S | In distribution | |
| 869-1051-1535-15-S | In distribution | |
| 869-1051-2540-17-S | In distribution | |
| 869-1051-3035-23-R | In distribution | |
| 869-1051-0835-15-S | In distribution | |
| 869-1051-0830-15-R | In distribution | |
| 869-1051-3040-21-S | In distribution | |
| 869-1051-3035-25-R | In distribution | |
| 869-1051-0830-15-S | In distribution | |
| 869-1051-1540-15-R | In distribution | |
| 869-1051-1535-13-S | In distribution | |
| 869-1051-1540-17-R | In distribution | |
| 869-1051-3040-21-R | In distribution | |
| 869-1051-0840-17-R | In distribution | |
| 869-1051-3040-23-R | In distribution | |
| 869-1051-0835-15-R | In distribution | |
| 869-1051-2030-15-S | In distribution | |
| 869-1051-2040-21-S | In distribution | |
| 869-1051-2535-17-R | In distribution | |
| 869-1051-0830-19-S | In distribution | |
| 869-1051-1535-11-R | In distribution | |
| 869-1051-0840-14-R | In distribution | |
| 869-1051-0835-14-R | In distribution | |
| 869-1051-1530-17-S | In distribution | |
| 869-1051-1540-21-S | In distribution | |
| 869-1051-3030-25-S | In distribution | |
| 869-1051-3040-25-R | In distribution | |
| 869-1051-1535-19-R | In distribution | |
| 869-1051-0840-21-S | In distribution | |
| 869-1051-3030-21-R | In distribution | |
| 869-1051-2540-21-R | In distribution | |
| 869-1051-3035-19-R | In distribution | |
| 869-1051-2035-19-S | In distribution | |
| 869-1051-1540-11-S | In distribution | |
| 869-1051-2530-17-S | In distribution | |
| 869-1051-0830-19-R | In distribution | |
| 869-1051-1540-15-S | In distribution | |
| 869-1051-1535-17-R | In distribution | |
| 869-1051-1540-14-S | In distribution | |
| 869-1051-2530-21-R | In distribution | |
| 869-1051-1540-19-S | In distribution | |
| 869-1051-2035-14-R | In distribution | |
| 869-1051-2530-15-R | In distribution | |
| 869-1051-1530-14-S | In distribution | |
| 869-1051-3030-17-S | In distribution | |
| 869-1051-1535-14-S | In distribution | |
| 869-1051-1535-21-S | In distribution | |
| 869-1051-0835-11-S | In distribution | |
| 869-1051-0840-12-R | In distribution | |
| 869-1051-3030-19-R | In distribution | |
| 869-1051-1530-15-R | In distribution | |
| 869-1051-0835-17-S | In distribution | |
| 869-1051-2030-19-R | In distribution | |
| 869-1051-1530-19-R | In distribution | |
| 869-1051-1530-19-S | In distribution | |
| 869-1051-2035-13-S | In distribution | |
| 869-1051-2530-17-R | In distribution | |
| 869-1051-2040-15-R | In distribution | |
| 869-1051-0835-19-R | In distribution | |
| 869-1051-0835-12-S | In distribution | |
| 869-1051-3035-19-S | In distribution | |
| 869-1051-1535-21-R | In distribution | |
| 869-1051-2035-19-R | In distribution | |
| 869-1051-1530-12-S | In distribution | |
| 869-1051-1530-11-R | In distribution | |
| 869-1051-1540-13-R | In distribution | |
| 869-1051-0830-11-S | In distribution | |
| 869-1051-1530-15-S | In distribution | |
| 869-1051-0840-15-R | In distribution | |
| 869-1051-2030-19-S | In distribution | |
| 869-1051-2030-13-R | In distribution | |
| 869-1051-2030-17-R | In distribution | |
| 869-1051-2035-14-S | In distribution | |
| 869-1051-3030-25-R | In distribution | |
| 869-1051-3035-21-S | In distribution | |
| 869-1051-1540-17-S | In distribution | |
| 869-1051-3030-23-R | In distribution | |
| 869-1051-1535-17-S | In distribution | |
| 869-1051-0830-13-S | In distribution | |
| 869-1051-0835-13-S | In distribution | |
| 869-1051-1535-14-R | In distribution | |
| 869-1051-2035-21-R | In distribution | |
| 869-1051-2035-17-S | In distribution | |
| 869-1051-0830-14-S | In distribution | |
| 869-1051-2040-19-R | In distribution | |
| 869-1051-1540-19-R | In distribution | |
| 869-1051-0835-14-S | In distribution | |
| 869-1051-0840-14-S | In distribution | |
| 869-1051-1535-15-R | In distribution | |
| 869-1051-2530-21-S | In distribution | |
| 869-1051-3035-17-R | In distribution | |
| 869-1051-3040-25-S | In distribution | |
| 869-1051-3040-23-S | In distribution | |
| 869-1051-1535-13-R | In distribution | |
| 869-1051-2540-19-S | In distribution | |
| 869-1051-2040-21-R | In distribution | |
| 869-1051-3035-21-R | In distribution | |
| 869-1051-0840-11-S | In distribution | |
| 869-1051-1540-12-R | In distribution | |
| 869-1051-3030-23-S | In distribution | |
| 869-1051-2030-14-S | In distribution | |
| 869-1051-0835-19-S | In distribution | |
| 869-1051-1540-12-S | In distribution | |
| 869-1051-2030-15-R | In distribution | |
| 869-1051-1530-13-S | In distribution | |
| 869-1051-0840-13-R | In distribution | |
| 869-1051-0830-12-S | In distribution | |
| 869-1051-2530-19-S | In distribution | |
| 869-1051-0840-13-S | In distribution | |
| 869-1051-2535-21-S | In distribution | |
| 869-1051-2040-17-S | In distribution | |
| 869-1051-1535-12-R | In distribution | |
| 869-1051-0835-21-S | In distribution | |
| 869-1051-0830-17-S | In distribution | |
| 869-1051-2540-17-R | In distribution | |
| 869-1051-0835-17-R | In distribution | |
| 869-1051-0840-12-S | In distribution | |
| 869-1051-2030-13-S | In distribution | |
| 869-1051-0840-17-S | In distribution | |
| 869-1051-3035-17-S | In distribution | |
| 869-1051-0830-17-R | In distribution | |
| 869-1051-1535-19-S | In distribution | |
| 869-1051-2535-15-S | In distribution | |
| 869-1051-2035-17-R | In distribution | |
| 869-1051-0830-14-R | In distribution | |
| 869-1051-2535-19-R | In distribution | |
| 869-1051-2540-21-S | In distribution | |
| 869-1051-2535-21-R | In distribution | |
| 869-1051-3030-17-R | In distribution | |
| 869-1051-0840-19-R | In distribution | |
| 869-1051-2035-15-R | In distribution | |
| 869-1051-3035-23-S | In distribution | |
| 869-1051-1535-12-S | In distribution | |
| 869-1051-1535-11-S | In distribution | |
| 869-1051-0835-21-R | In distribution | |
| 869-1051-0835-11-R | In distribution | |
| 869-1051-2040-17-R | In distribution | |
| 869-1051-0835-13-R | In distribution | |
| 869-1051-1530-11-S | In distribution | |
| 869-1051-0840-21-R | In distribution | |
| 869-1051-2030-14-R | In distribution | |
| 869-1051-2535-15-R | In distribution | |
| 869-1051-0830-13-R | In distribution | |
| 869-1051-1540-14-R | In distribution | |
| 869-1051-0840-11-R | In distribution | |
| 869-1051-0840-15-S | In distribution | |
| 869-1051-3030-15-R | In distribution | |
| 869-1051-1540-13-S | In distribution | |
| 869-1051-2035-15-S | In distribution | |
| 869-1051-3030-21-S | In distribution | |
| 869-1051-1530-14-R | In distribution | |
| 869-1051-1540-21-R | In distribution | |
| 869-1051-2035-13-R | In distribution | |
| 869-1051-2540-19-R | In distribution | |
| 869-1051-2535-19-S | In distribution | |
| 869-1051-2040-19-S | In distribution | |
| 869-1051-2530-15-S | In distribution | |
| 869-1051-0835-12-R | In distribution | |
| 869-1051-0830-11-R | Withdrawn | |
| 869-1051-0830-12-R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142271 | 2014-12-19 |
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.