Tranquil-C™

Cervical Rasp, Thin Shaft, 10x18x14, 6 deg

Registry build 21.09.26
12manufacturers in China registered for this device type
158catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (4), Guangdong (3), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HTR
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Shanghai Lions Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 82
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Changzhou Jiangsu Contract manufacturer 25
Shenzhen Xiazhifeng Electronic Co., Ltd. Shenzhen Guangdong Contract manufacturer 25

Record

Regulatory record for Tranquil-C™
Listed by Nexus Spine, L.L.C., United States
FDA product code HTR
Device type Rasp
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2021-12-17
Record revised 2024-07-11 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number
Sizes Width 12 to 18 mm; length 11 to 14 mm; height 5 to 12 mm

Catalogue Numbers

Catalogue numbers for Tranquil-C™
Catalogue number Size Status
822543 Width 18 mm In distribution
822544 Width 18 mm In distribution
822478CT1 Width 14 mm In distribution
822476CT1 Width 14 mm In distribution
822375 Width 12 mm In distribution
822694 Width 14 mm In distribution
822377 Width 14 mm In distribution
822547 Width 18 mm In distribution
822371 Width 12 mm In distribution
822370 Width 12 mm In distribution
822701 Width 16 mm In distribution
822397 Width 18 mm In distribution
822534 Width 16 mm In distribution
822379 Width 14 mm In distribution
822524 Width 14 mm In distribution
822691 Width 14 mm In distribution
822390 Width 16 mm In distribution
822252 Width 16 mm In distribution
822396 Width 18 mm In distribution
822380 Width 14 mm In distribution
822692 Width 14 mm In distribution
822341 Width 18 mm In distribution
822489CT1 Width 16 mm In distribution
822536 Width 16 mm In distribution
822233 Width 12 mm In distribution
822339 Width 18 mm In distribution
822231 Width 12 mm In distribution
822710 Width 18 mm In distribution
822389 Width 16 mm In distribution
822381 Width 14 mm In distribution
822538 Width 16 mm In distribution
822250 Width 16 mm In distribution
822237 Width 12 mm In distribution
822240 Width 14 mm In distribution
822532 Width 16 mm In distribution
822244 Width 14 mm In distribution
822343 Width 18 mm In distribution
822394 Width 18 mm In distribution
822535 Width 16 mm In distribution
822711 Width 18 mm In distribution
822477CT1 Width 14 mm In distribution
822496 Width 18 mm In distribution
822332 Width 16 mm In distribution
822249 Width 16 mm In distribution
822693 Width 14 mm In distribution
822488 Width 16 mm In distribution
822542 Width 18 mm In distribution
822481 Width 14 mm In distribution
822499 Width 18 mm In distribution
822247 Width 16 mm In distribution
822378 Width 14 mm In distribution
822690 Width 14 mm In distribution
822393 Width 18 mm In distribution
822474 Width 12 mm In distribution
822546 Width 18 mm In distribution
822333 Width 16 mm In distribution
822485CT1 Width 16 mm In distribution
822242 Width 14 mm In distribution
822485 Width 16 mm In distribution
822540 Width 18 mm In distribution
822340 Width 18 mm In distribution
822387 Width 16 mm In distribution
822373 Width 12 mm In distribution
822251 Width 16 mm In distribution
822471 Width 12 mm In distribution
822391 Width 16 mm In distribution
822342 Width 18 mm In distribution
822245 Width 14 mm In distribution
822236 Width 12 mm In distribution
822526 Width 14 mm In distribution
822368 Width 12 mm In distribution
822388 Width 16 mm In distribution
822239 Width 14 mm In distribution
822708 Width 18 mm In distribution
822531 Width 14 mm In distribution
822344 Width 18 mm In distribution
822336 Width 16 mm In distribution
822337 Width 16 mm In distribution
822709 Width 18 mm In distribution
822707 Width 18 mm In distribution
822473 Width 12 mm In distribution
822246 Width 14 mm In distribution
822495 Width 18 mm In distribution
822481CT1 Width 14 mm In distribution
822335 Width 16 mm In distribution
822241 Width 14 mm In distribution
822527 Width 14 mm In distribution
822238 Width 12 mm In distribution
822384 Width 16 mm In distribution
822533 Width 16 mm In distribution
822331 Width 16 mm In distribution
822525 Width 14 mm In distribution
822700 Width 16 mm In distribution
822491 Width 16 mm In distribution
822492 Width 18 mm In distribution
822470 Width 12 mm In distribution
822480 Width 14 mm In distribution
822376 Width 14 mm In distribution
822480CT1 Width 14 mm In distribution
822702 Width 16 mm In distribution
822486CT1 Width 16 mm In distribution
822528 Width 14 mm In distribution
822398 Width 18 mm In distribution
822334 Width 16 mm In distribution
822489 Width 16 mm In distribution
822545 Width 18 mm In distribution
822475 Width 12 mm In distribution
822369 Width 12 mm In distribution
822493 Width 18 mm In distribution
822490 Width 16 mm In distribution
822486 Width 16 mm In distribution
822385 Width 16 mm In distribution
822487CT1 Width 16 mm In distribution
822399 Width 18 mm In distribution
822483 Width 14 mm In distribution
822234 Width 12 mm In distribution
822395 Width 18 mm In distribution
822476 Width 14 mm In distribution
822497 Width 18 mm In distribution
822383 Width 14 mm In distribution
822706 Width 18 mm In distribution
822392 Width 18 mm In distribution
822699 Width 16 mm In distribution
822484 Width 16 mm In distribution
822703 Width 16 mm In distribution
822695 Width 14 mm In distribution
822478 Width 14 mm In distribution
822346 Width 18 mm In distribution
822698 Width 16 mm In distribution
822477 Width 14 mm In distribution
822303 Width 12 mm In distribution
822232 Width 12 mm In distribution
822487 Width 16 mm In distribution
822498 Width 18 mm In distribution
822479CT1 Width 14 mm In distribution
822374 Width 12 mm In distribution
822382 Width 14 mm In distribution
822484CT1 Width 16 mm In distribution
822482 Width 14 mm In distribution
822243 Width 14 mm In distribution
822386 Width 16 mm In distribution
822338 Width 16 mm In distribution
822468 Width 12 mm In distribution
822541 Width 18 mm In distribution
822530 Width 14 mm In distribution
822479 Width 14 mm In distribution
822494 Width 18 mm In distribution
822537 Width 16 mm In distribution
822539 Width 16 mm In distribution
822372 Width 12 mm In distribution
822469 Width 12 mm In distribution
822367 Width 12 mm In distribution
822529 Width 14 mm In distribution
822472 Width 12 mm In distribution
822248 Width 16 mm In distribution
822235 Width 12 mm In distribution
822345 Width 18 mm In distribution
822488CT1 Width 16 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 240
TiWAVE C Cervical Cage System Kalitec Direct, LLC 232
Calix Spinal Implant System Xtant Medical Holdings, Inc. 143
Rasp Medtronic Sofamor Danek, Inc. 109
Specials Seaspine Orthopedics Corporation 109
Stryker Avalign Technologies, Inc. 105
Endoskeleton® TAS Medtronic Sofamor Danek, Inc. 93
Intervertebral Disc Preparation Instruments Alphatec Spine, Inc. 90
Cambria Seaspine Orthopedics Corporation 85
IdentiTi Alphatec Spine, Inc. 83
Link Instruments – Rasps, compressors and broaches Waldemar Link GmbH & Co. KG 83
Rasp Zimmer, Inc. 77

Showing 12 of 378. All products under Rasp

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer