Zavation
Posterior Lateral Screw 11.0mmx45mm
3manufacturers in China registered for this device type
75catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Shandong (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 |
| Autocam Medical Devices (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
Record
| Listed by | Zavation, United States |
|---|---|
| FDA product code | OUR |
| Device type | Sacroiliac Joint Fixation |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K173752 |
| Record published | 2022-04-18 |
| Record revised | 2025-07-02 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 730-12535 | In distribution | |
| 240-2010 | In distribution | |
| 730-2003-110 | In distribution | |
| 770-11045 | In distribution | |
| 770-1007 | In distribution | |
| 730-2005 | In distribution | |
| 770-11055 | In distribution | |
| 730-12550 | In distribution | |
| 770-1003 | In distribution | |
| 770-1005-125 | In distribution | |
| 730-12565 | In distribution | |
| 730-12540 | In distribution | |
| 240-9050 | In distribution | |
| 770-12540 | In distribution | |
| 730-11060 | In distribution | |
| 730-2011 | In distribution | |
| 730-12555 | In distribution | |
| 770-12565 | In distribution | |
| 730-2007 | In distribution | |
| 770-12570 | In distribution | |
| 730-11040 | In distribution | |
| 730-2002 | In distribution | |
| 770-11070 | In distribution | |
| 770-11050 | In distribution | |
| 770-12545 | In distribution | |
| 730-2008 | In distribution | |
| 770-12555 | In distribution | |
| 770-1002 | In distribution | |
| 770-1004 | In distribution | |
| ZAV-1335 | In distribution | |
| 240-2012 | In distribution | |
| 240-9050SS | In distribution | |
| 770-11075 | In distribution | |
| Z-1027 | In distribution | |
| 240-9030 | In distribution | |
| 730-2003-125 | In distribution | |
| 730-11050 | In distribution | |
| 240-2002 | In distribution | |
| 730-2004 | In distribution | |
| 240-9040SS | In distribution | |
| 730-12560 | In distribution | |
| 730-11045 | In distribution | |
| 240-2004 | In distribution | |
| 770-9000 | In distribution | |
| 730-12545 | In distribution | |
| 730-2012 | In distribution | |
| 730-11055 | In distribution | |
| 770-12575 | In distribution | |
| 770-11035 | In distribution | |
| 730-12570 | In distribution | |
| 730-2005-1 | In distribution | |
| 730-11070 | In distribution | |
| 770-12560 | In distribution | |
| 770-12550 | In distribution | |
| 770-11060 | In distribution | |
| 770-1005-110 | In distribution | |
| 770-1006 | In distribution | |
| 730-12575 | In distribution | |
| 730-2001 | In distribution | |
| 730-2009 | In distribution | |
| 730-11035 | In distribution | |
| 770-11065 | In distribution | |
| 240-2013 | In distribution | |
| 730-2014 | In distribution | |
| 730-11065 | In distribution | |
| 770-11040 | In distribution | |
| ZAV-1132 | In distribution | |
| 730-11075 | In distribution | |
| 770-1008 | In distribution | |
| 730-2013-19 | In distribution | |
| 240-2006 | In distribution | |
| 770-1001 | In distribution | |
| 730-2013-17 | In distribution | |
| 240-9040 | In distribution | |
| 770-12535 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SI-LOK | Globus Medical, Inc. | 666 |
| Sacroiliac Joint Fusion System | Genesys Orthopedics Systems, LLC | 356 |
| SIros-X | Genesys Orthopedics Systems, LLC | 353 |
| PathLoc- SI Joint Fusion System | L&K Biomed Co., Ltd. | 229 |
| ARx SAI | Life Spine | 224 |
| Unity | Diomedical Co., Ltd. | 198 |
| SImmetry SI Joint Fusion System | Tenon Medical, Inc. | 173 |
| M.u.s.t. Sacral Iliac Screw and Pelvic Trauma System | Medacta International SA | 170 |
| Integrity-SI Fusion System | Lincotek Medical, LLC | 160 |
| Zespin SI Joint Fusion System | Aegis Spine | 150 |
| M.u.s.t. Sacral Iliac Screw System | Medacta International SA | 142 |
| Simmetry | Sivantage | 123 |
Showing 12 of 534. All products under Sacroiliac Joint Fixation
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.