Stable-L™
Stable-L Torque Limiting Tri-lobe Handle - 38 in-lb
3manufacturers in China registered for this device type
133catalogue numbers in this listing
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 | Nexus Spine, L.L.C., 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 | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K231486 |
| Record published | 2024-05-01 |
| Record revised | 2026-06-23 (version 5) |
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 | 2023-06-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 525214 | In distribution | |
| 525207S | In distribution | |
| 525156S | In distribution | |
| 525202S | In distribution | |
| 525179S | In distribution | |
| 525221 | In distribution | |
| 525167S | In distribution | |
| 525192 | In distribution | |
| 525158 | In distribution | |
| 525187 | In distribution | |
| 525164 | In distribution | |
| 525193 | In distribution | |
| 525151 | In distribution | |
| 525165 | In distribution | |
| 525182S | In distribution | |
| 525200S | In distribution | |
| 525169S | In distribution | |
| 525154 | In distribution | |
| 525186 | In distribution | |
| 525167 | In distribution | |
| 525187S | In distribution | |
| 525204 | In distribution | |
| 525161S | In distribution | |
| 525184S | In distribution | |
| 525160S | In distribution | |
| 525192S | In distribution | |
| 525189 | In distribution | |
| 525215 | In distribution | |
| 525208 | In distribution | |
| 525175 | In distribution | |
| 525188S | In distribution | |
| 525170 | In distribution | |
| 525180 | In distribution | |
| 525212 | In distribution | |
| 525193S | In distribution | |
| 525150 | In distribution | |
| 525165S | In distribution | |
| 525208S | In distribution | |
| 525183S | In distribution | |
| 525155S | In distribution | |
| 525210 | In distribution | |
| 525213 | In distribution | |
| 525181 | In distribution | |
| 525205 | In distribution | |
| 525171S | In distribution | |
| 525205S | In distribution | |
| 525196S | In distribution | |
| 525220 | In distribution | |
| 525199S | In distribution | |
| 525216 | In distribution | |
| 525182 | In distribution | |
| 525144 | In distribution | |
| 525149 | In distribution | |
| 525189S | In distribution | |
| 525210S | In distribution | |
| 525185 | In distribution | |
| 525195 | In distribution | |
| 525176S | In distribution | |
| 525159 | In distribution | |
| 525162 | In distribution | |
| 525173S | In distribution | |
| 525185S | In distribution | |
| 525211 | In distribution | |
| 525162S | In distribution | |
| 525195S | In distribution | |
| 525158S | In distribution | |
| 525178S | In distribution | |
| 525177S | In distribution | |
| 525219 | In distribution | |
| 525154S | In distribution | |
| 525159S | In distribution | |
| 525157S | In distribution | |
| 525207 | In distribution | |
| 525199 | In distribution | |
| 525175S | In distribution | |
| 525209S | In distribution | |
| 525202 | In distribution | |
| 525145 | In distribution | |
| 525169 | In distribution | |
| 525172 | In distribution | |
| 525188 | In distribution | |
| 525164S | In distribution | |
| 525170S | In distribution | |
| 525163S | In distribution | |
| 525173 | In distribution | |
| 525217 | In distribution | |
| 525160 | In distribution | |
| 525178 | In distribution | |
| 525200 | In distribution | |
| 525194S | In distribution | |
| 525171 | In distribution | |
| 525191S | In distribution | |
| 525183 | In distribution | |
| v | In distribution | |
| 525174 | In distribution | |
| 525203S | In distribution | |
| 525168S | In distribution | |
| 525197 | In distribution | |
| 525191 | In distribution | |
| 525222 | In distribution | |
| 525197S | In distribution | |
| 525184 | In distribution | |
| 525146 | In distribution | |
| 525196 | In distribution | |
| 525156 | In distribution | |
| 525163 | In distribution | |
| 525174S | In distribution | |
| 525161 | In distribution | |
| 525181S | In distribution | |
| 525206 | In distribution | |
| 525194 | In distribution | |
| 525172S | In distribution | |
| 525180S | In distribution | |
| 525176 | In distribution | |
| 525209 | In distribution | |
| 525204S | In distribution | |
| 525177 | In distribution | |
| 525190S | In distribution | |
| 525157 | In distribution | |
| 525201S | In distribution | |
| 525198 | In distribution | |
| 525201 | In distribution | |
| 525166 | In distribution | |
| 525198S | In distribution | |
| 525168 | In distribution | |
| 525155 | In distribution | |
| 525166S | In distribution | |
| 525206S | In distribution | |
| 525218 | In distribution | |
| 525203 | In distribution | |
| 525179 | In distribution | |
| 525186S | In distribution | |
| 825189 | 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
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.