Tranquil-C™
Cervical IBD 10x18x14 Convex, 6 Deg, 0.26 cc
14manufacturers in China registered for this device type
234catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | Nexus Spine, L.L.C., United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K170297 |
| Record published | 2021-12-17 |
| Record revised | 2024-09-11 (version 4) |
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 |
| Sizes | Length 9 to 15 mm; width 12 to 20 mm; height 5 to 12 mm |
| Distribution end date | 2023-06-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 522417 | Width 16 mm | In distribution |
| 522362 | Width 18 mm | In distribution |
| 522961 | Width 14 mm | In distribution |
| 522261 | Width 14 mm | In distribution |
| 522400 | Width 20 mm | In distribution |
| 522208 | Width 12 mm | In distribution |
| 523330 | Width 14 mm | In distribution |
| 522371 | Width 18 mm | In distribution |
| 522404 | Width 20 mm | In distribution |
| 522247 | Width 16 mm | In distribution |
| 522207 | Width 12 mm | In distribution |
| 523358 | Width 14 mm | In distribution |
| 522225 | Width 12 mm | In distribution |
| 523375 | Width 18 mm | In distribution |
| 522254 | Width 12 mm | In distribution |
| 522286 | Width 18 mm | In distribution |
| 522367 | Width 18 mm | In distribution |
| 522268 | Width 16 mm | In distribution |
| 522223 | Width 16 mm | In distribution |
| 522267 | Width 16 mm | In distribution |
| 522964 | Width 16 mm | In distribution |
| 522252 | Width 12 mm | In distribution |
| 522235 | Width 14 mm | In distribution |
| 522280 | Width 16 mm | In distribution |
| 522206 | Width 12 mm | In distribution |
| 522408 | Width 14 mm | In distribution |
| 522382 | Width 18 mm | In distribution |
| 522419 | Width 16 mm | In distribution |
| 522217 | Width 16 mm | In distribution |
| 522201 | Width 12 mm | In distribution |
| 522204 | Width 12 mm | In distribution |
| 522233 | Width 14 mm | In distribution |
| 523369 | Width 18 mm | In distribution |
| 522966 | Width 16 mm | In distribution |
| 522977 | Width 18 mm | In distribution |
| 522270 | Width 16 mm | In distribution |
| 522416 | Width 16 mm | In distribution |
| 523339 | Width 16 mm | In distribution |
| 522202 | Width 12 mm | In distribution |
| 522211 | Width 14 mm | In distribution |
| 522957 | Width 14 mm | In distribution |
| 523355 | Width 14 mm | In distribution |
| 523341 | Width 16 mm | In distribution |
| 522414 | Width 16 mm | In distribution |
| 522956 | Width 14 mm | In distribution |
| 522391 | Width 20 mm | In distribution |
| 522212 | Width 14 mm | In distribution |
| 522384 | Width 18 mm | In distribution |
| 523356 | Width 14 mm | In distribution |
| 522399 | Width 20 mm | In distribution |
| 522361 | Width 18 mm | In distribution |
| 822225 | In distribution | |
| 522971 | Width 16 mm | In distribution |
| 522275 | Width 16 mm | In distribution |
| 522390 | Width 20 mm | In distribution |
| 522420 | Width 16 mm | In distribution |
| 523332 | Width 14 mm | In distribution |
| 522375 | Width 18 mm | In distribution |
| 522256 | Width 12 mm | In distribution |
| 522248 | Width 16 mm | In distribution |
| 523346 | Width 18 mm | In distribution |
| 522354 | Width 16 mm | In distribution |
| 523334 | Width 14 mm | In distribution |
| 522234 | Width 14 mm | In distribution |
| 522220 | Width 16 mm | In distribution |
| 522210 | Width 14 mm | In distribution |
| 523370 | Width 18 mm | In distribution |
| 522240 | Width 14 mm | In distribution |
| 522398 | Width 20 mm | In distribution |
| 523376 | Width 18 mm | In distribution |
| 522251 | Width 12 mm | In distribution |
| 522283 | Width 18 mm | In distribution |
| 522269 | Width 16 mm | In distribution |
| 522284 | Width 18 mm | In distribution |
| 522365 | Width 18 mm | In distribution |
| 523343 | Width 16 mm | In distribution |
| 522222 | Width 16 mm | In distribution |
| 522959 | Width 14 mm | In distribution |
| 522282 | Width 18 mm | In distribution |
| 522363 | Width 18 mm | In distribution |
| 522403 | Width 20 mm | In distribution |
| 522352 | Width 16 mm | In distribution |
| 522209 | Width 14 mm | In distribution |
| 522238 | Width 14 mm | In distribution |
| 522965 | Width 16 mm | In distribution |
| 523368 | Width 16 mm | In distribution |
| 522392 | Width 20 mm | In distribution |
| 522389 | Width 20 mm | In distribution |
| 522216 | Width 14 mm | In distribution |
| 522379 | Width 18 mm | In distribution |
| 522366 | Width 18 mm | In distribution |
| 522972 | Width 18 mm | In distribution |
| 522406 | Width 14 mm | In distribution |
| 522355 | Width 16 mm | In distribution |
| 522381 | Width 18 mm | In distribution |
| 522368 | Width 18 mm | In distribution |
| 522393 | Width 20 mm | In distribution |
| 523365 | Width 16 mm | In distribution |
| 523374 | Width 18 mm | In distribution |
| 523348 | Width 18 mm | In distribution |
| 522385 | Width 18 mm | In distribution |
| 522229 | Width 12 mm | In distribution |
| 523349 | Width 18 mm | In distribution |
| 522378 | Width 18 mm | In distribution |
| 523359 | Width 14 mm | In distribution |
| 522415 | Width 16 mm | In distribution |
| 522958 | Width 14 mm | In distribution |
| 522358 | Width 18 mm | In distribution |
| 522243 | Width 16 mm | In distribution |
| 522205 | Width 12 mm | In distribution |
| 522224 | Width 16 mm | In distribution |
| 522273 | Width 16 mm | In distribution |
| 522263 | Width 14 mm | In distribution |
| 522231 | Width 12 mm | In distribution |
| 523338 | Width 16 mm | In distribution |
| 523331 | Width 14 mm | In distribution |
| 522970 | Width 16 mm | In distribution |
| 522410 | Width 14 mm | In distribution |
| 523357 | Width 14 mm | In distribution |
| 522374 | Width 18 mm | In distribution |
| 522203 | Width 12 mm | In distribution |
| 522288 | Width 18 mm | In distribution |
| 523373 | Width 18 mm | In distribution |
| 522395 | Width 20 mm | In distribution |
| 523354 | Width 14 mm | In distribution |
| 522228 | Height 8 mm | In distribution |
| 522264 | Width 14 mm | In distribution |
| 522253 | Width 12 mm | In distribution |
| 522370 | Width 18 mm | In distribution |
| 522215 | Width 14 mm | In distribution |
| 522271 | Width 16 mm | In distribution |
| 522285 | Width 18 mm | In distribution |
| 523360 | Width 14 mm | In distribution |
| 522397 | Width 20 mm | In distribution |
| 522260 | Width 14 mm | In distribution |
| 522978 | Width 18 mm | In distribution |
| 522257 | Width 14 mm | In distribution |
| 522278 | Width 16 mm | In distribution |
| 522376 | Width 18 mm | In distribution |
| 522241 | Width 16 mm | In distribution |
| 522356 | Width 16 mm | In distribution |
| 522412 | Width 14 mm | In distribution |
| 522386 | Width 18 mm | In distribution |
| 523351 | Width 18 mm | In distribution |
| 522360 | Width 18 mm | In distribution |
| 522967 | Width 16 mm | In distribution |
| 523336 | Width 14 mm | In distribution |
| 523364 | Width 16 mm | In distribution |
| 523371 | Width 18 mm | In distribution |
| 523350 | Width 18 mm | In distribution |
| 522402 | Width 20 mm | In distribution |
| 522349 | Width 16 mm | In distribution |
| 522279 | Width 16 mm | In distribution |
| 523333 | Width 14 mm | In distribution |
| 523335 | Width 14 mm | In distribution |
| 522242 | Width 16 mm | In distribution |
| 522237 | Width 14 mm | In distribution |
| 522979 | Width 18 mm | In distribution |
| 522372 | Width 18 mm | In distribution |
| 523344 | Width 16 mm | In distribution |
| 523363 | Width 16 mm | In distribution |
| 522213 | Width 14 mm | In distribution |
| 522976 | Width 18 mm | In distribution |
| 522262 | Width 14 mm | In distribution |
| 522232 | Width 12 mm | In distribution |
| 522244 | Width 16 mm | In distribution |
| 522227 | Width 12 mm | In distribution |
| 522281 | Width 18 mm | In distribution |
| 522287 | Width 18 mm | In distribution |
| 522274 | Width 16 mm | In distribution |
| 522963 | Width 14 mm | In distribution |
| 522380 | Width 18 mm | In distribution |
| 523352 | Width 18 mm | In distribution |
| 522350 | Width 16 mm | In distribution |
| 522377 | Width 18 mm | In distribution |
| 522214 | Width 14 mm | In distribution |
| 522221 | Width 16 mm | In distribution |
| 522219 | Width 16 mm | In distribution |
| 522383 | Width 18 mm | In distribution |
| 523347 | Width 18 mm | In distribution |
| 522351 | Width 16 mm | In distribution |
| 522413 | Width 16 mm | In distribution |
| 523361 | Width 16 mm | In distribution |
| 522373 | Width 18 mm | In distribution |
| 523337 | Width 16 mm | In distribution |
| 522276 | Width 16 mm | In distribution |
| 522359 | Width 18 mm | In distribution |
| 522968 | Width 16 mm | In distribution |
| 522259 | Width 14 mm | In distribution |
| 522394 | Width 20 mm | In distribution |
| 523366 | Width 16 mm | In distribution |
| 523367 | Width 16 mm | In distribution |
| 522396 | Width 20 mm | In distribution |
| 522409 | Width 14 mm | In distribution |
| 522353 | Width 16 mm | In distribution |
| 522388 | Width 18 mm | In distribution |
| 523345 | Width 18 mm | In distribution |
| 522245 | Width 16 mm | In distribution |
| 522407 | Width 14 mm | In distribution |
| 523342 | Width 16 mm | In distribution |
| 522387 | Width 18 mm | In distribution |
| 523353 | Width 14 mm | In distribution |
| 522266 | Width 16 mm | In distribution |
| 522369 | Width 18 mm | In distribution |
| 522357 | Width 18 mm | In distribution |
| 522411 | Width 14 mm | In distribution |
| 522969 | Width 16 mm | In distribution |
| 522973 | Width 18 mm | In distribution |
| 522250 | Width 12 mm | In distribution |
| 522418 | Width 16 mm | In distribution |
| 522962 | Width 14 mm | In distribution |
| 522249 | Width 12 mm | In distribution |
| 522226 | Width 12 mm | In distribution |
| 522236 | Width 14 mm | In distribution |
| 523362 | Width 16 mm | In distribution |
| 522960 | Width 14 mm | In distribution |
| 522975 | Width 18 mm | In distribution |
| 523329 | Width 14 mm | In distribution |
| 522401 | Width 20 mm | In distribution |
| 522246 | Width 16 mm | In distribution |
| 522255 | Width 12 mm | In distribution |
| 522974 | Width 18 mm | In distribution |
| 522265 | Width 16 mm | In distribution |
| 522272 | Width 16 mm | In distribution |
| 522277 | Width 16 mm | In distribution |
| 522239 | Width 14 mm | In distribution |
| 523340 | Width 16 mm | In distribution |
| 522364 | Width 18 mm | In distribution |
| 522258 | Width 14 mm | In distribution |
| 522405 | Width 14 mm | In distribution |
| 522218 | Width 16 mm | In distribution |
| 523372 | Width 18 mm | In distribution |
| 522230 | Width 12 mm | In distribution |
| 822226 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Evos Lumbar Interbody System | Cutting Edge Spine | 1,871 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, Inc. |
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.