VBR
artificial pedicle - shaft
3manufacturers in China registered for this device type
245catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Coligne AG, Switzerland |
|---|---|
| FDA product code | MQP |
| Device type | Spinal Vertebral Body Replacement Device |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3060 |
| Establishment | Manufacturer |
| 510(k) | K072326 |
| Record published | 2016-09-24 |
| Record revised | 2020-02-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2019-08-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 068.245 | In distribution | |
| 068.150 | In distribution | |
| 2384 | In distribution | |
| 068.251 | In distribution | |
| 068.147 | In distribution | |
| 2385 | In distribution | |
| 068.630.100 | In distribution | |
| 2360 | In distribution | |
| 65.650 | In distribution | |
| 4392 | In distribution | |
| 068.630.040 | In distribution | |
| 4386 | In distribution | |
| 068.240 | In distribution | |
| 068.232 | In distribution | |
| P15.010.236 | In distribution | |
| 068.136 | In distribution | |
| 068.138 | In distribution | |
| 068.152 | In distribution | |
| 068.630.060 | In distribution | |
| P15.010.351 | In distribution | |
| 2374 | In distribution | |
| P15.010.221 | In distribution | |
| 2373 | In distribution | |
| 068.130 | In distribution | |
| 2382 | In distribution | |
| 068.620 | In distribution | |
| 2362 | In distribution | |
| 2368 | In distribution | |
| 068.151 | In distribution | |
| 068.630.140 | In distribution | |
| 068.630.080 | In distribution | |
| 068.630.070 | In distribution | |
| P15.010.501 | In distribution | |
| 068.140 | In distribution | |
| 2366 | In distribution | |
| P15.010.191 | In distribution | |
| 068.610 | In distribution | |
| 068.241 | In distribution | |
| P15.010.301 | In distribution | |
| 4388 | In distribution | |
| 068.146 | In distribution | |
| 068.630.050 | In distribution | |
| 2367 | In distribution | |
| 068.246 | In distribution | |
| P15.010.401 | In distribution | |
| 068.640 | In distribution | |
| P15.010.176 | In distribution | |
| 068.630.200 | In distribution | |
| P15.010.476 | In distribution | |
| 65.660 | In distribution | |
| 068.630.120 | In distribution | |
| 068.238 | In distribution | |
| 2375 | In distribution | |
| 068.230 | In distribution | |
| 068.250 | In distribution | |
| 2381 | In distribution | |
| 068.145 | In distribution | |
| 2383 | In distribution | |
| 068.141 | In distribution | |
| 068.142 | In distribution | |
| P15.010.276 | In distribution | |
| P15.010.526 | In distribution | |
| 068.630.130 | In distribution | |
| 2380 | In distribution | |
| 65.670 | In distribution | |
| 2361 | In distribution | |
| P15.010.426 | In distribution | |
| P15.010.206 | In distribution | |
| 4390 | In distribution | |
| P15.010.376 | In distribution | |
| 068.247 | In distribution | |
| 4382 | In distribution | |
| 068.630.090 | In distribution | |
| 4384 | In distribution | |
| P15.010.251 | In distribution | |
| 068.252 | In distribution | |
| 068.630.110 | In distribution | |
| 4380 | In distribution | |
| 2364 | In distribution | |
| 2363 | In distribution | |
| 068.242 | In distribution | |
| P15.010.326 | In distribution | |
| P15.010.451 | In distribution | |
| 068.132 | In distribution | |
| 2365 | In distribution | |
| 2369 | In distribution | |
| 21.372 | In distribution | |
| 068.236 | In distribution | |
| 21.337 | Withdrawn | |
| 21.277 | Withdrawn | |
| 29.112 | Withdrawn | |
| 2306 | Withdrawn | |
| 20.042.113307 | Withdrawn | |
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| 2336 | Withdrawn | |
| 20.041.1309 | Withdrawn | |
| 65.677 | Withdrawn | |
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| 65.115 | Withdrawn | |
| 4331 | Withdrawn | |
| 2330 | Withdrawn | |
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| 21.297 | Withdrawn | |
| 4336 | Withdrawn | |
| 4335 | Withdrawn | |
| 2331 | Withdrawn | |
| 65.095 | Withdrawn | |
| 29.103 | Withdrawn | |
| 21.352 | Withdrawn | |
| 29.123 | Withdrawn | |
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| 20.042.093307 | Withdrawn | |
| 20.041.0905 | Withdrawn | |
| 29.114 | Withdrawn | |
| P45.2333 | Withdrawn | |
| 66.292 | Withdrawn | |
| 29.132 | Withdrawn | |
| 2353 | Withdrawn | |
| 21.295 | Withdrawn | |
| 2301 | Withdrawn | |
| 2304 | Withdrawn | |
| 4470 | Withdrawn | |
| 29.071 | Withdrawn | |
| 65.712 | Withdrawn | |
| 4376 | Withdrawn | |
| 65.132 | Withdrawn | |
| 66.115 | Withdrawn | |
| 65.735 | Withdrawn | |
| 2351 | Withdrawn | |
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| 20.042.133307 | Withdrawn | |
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| 2343 | Withdrawn | |
| 65.112 | Withdrawn | |
| 29.084 | Withdrawn | |
| 015.030.326 | Withdrawn | |
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| 21.292 | Withdrawn | |
| 2329 | Withdrawn | |
| 2313 | Withdrawn | |
| 20.041.1105 | Withdrawn | |
| 29.111 | Withdrawn | |
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| 2312 | Withdrawn | |
| 015.030.426 | Withdrawn | |
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| 2350 | Withdrawn | |
| 65.092 | Withdrawn | |
| 015.030.526 | Withdrawn | |
| 015.030.376 | Withdrawn | |
| 21.315 | Withdrawn | |
| 3382 | Withdrawn | |
| 66.135 | Withdrawn | |
| 29.092 | Withdrawn | |
| 29.117 | Withdrawn | |
| 2311 | Withdrawn | |
| 2348 | Withdrawn | |
| 2337 | Withdrawn | |
| 2334 | Withdrawn | |
| 21.335 | Withdrawn | |
| 015.030.206 | Withdrawn | |
| 2341 | Withdrawn | |
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| 20.042.132807 | Withdrawn | |
| 65.075 | Withdrawn | |
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| 21.317 | Withdrawn | |
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| 29.091 | Withdrawn | |
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| 21.332 | Withdrawn | |
| 015.030.221 | Withdrawn | |
| 3380 | Withdrawn | |
| 65.695 | Withdrawn | |
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| 015.030.351 | Withdrawn | |
| 2347 | Withdrawn | |
| 2357 | Withdrawn | |
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| 2318 | Withdrawn | |
| 57.095 | Withdrawn | |
| 2339 | Withdrawn | |
| 29.118 | Withdrawn | |
| 015.030.451 | Withdrawn | |
| 4374 | Withdrawn | |
| 2354 | Withdrawn | |
| 4332 | Withdrawn | |
| 21.375 | Withdrawn | |
| 2309 | Withdrawn | |
| 21.275 | Withdrawn | |
| 053.050 | Withdrawn | |
| 3383 | Withdrawn | |
| 4480 | Withdrawn | |
| 21.357 | Withdrawn | |
| 21.355 | Withdrawn | |
| 29.072 | Withdrawn | |
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| 015.030.191 | Withdrawn | |
| 2307 | Withdrawn | |
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| 4378 | Withdrawn | |
| 015.030.176 | Withdrawn | |
| 015.030.276 | Withdrawn | |
| 66.315 | Withdrawn | |
| P45.2334 | Withdrawn | |
| 015.030.401 | Withdrawn | |
| 65.077 | Withdrawn | |
| 2321 | Withdrawn | |
| P45.2336 | Withdrawn | |
| 66.335 | Withdrawn | |
| 2346 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoRoent | Nuvasive, Inc. | 1,514 |
| Capri™ Corpectomy Cage System | VB Spine LLC | 1,509 |
| Aleutian® Interbody Systems | VB Spine LLC | 1,189 |
| Fortify | Globus Medical, Inc. | 866 |
| Matrixx System | Nexxt Spine LLC | 748 |
| Ascend | Alphatec Spine, Inc. | 555 |
| Zavation VBR Trial | Zavation | 548 |
| Verte-Stack® Spinal System | Medtronic Sofamor Danek, Inc. | 484 |
| Timberline® Lateral Interbody Fusion System | Biomet Spine | 470 |
| Timberline Lateral Fusion System | Biomet Spine | 459 |
| Novel | Alphatec Spine, Inc. | 447 |
| Hawkeye™ Vertebral Body Replacement (VBR) | Choice Spine, LP | 368 |
Showing 12 of 683. All products under Spinal Vertebral Body Replacement Device
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.