Specials

Trial Rasp W/ Slap Hammer Attachment,18x15x11mm

Registry build 21.09.26
12manufacturers in China registered for this device type
109catalogue 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 Specials
Listed by Seaspine Orthopedics Corporation, 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 2022-02-17
Record revised 2025-10-24 (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

Catalogue Numbers

Catalogue numbers for Specials
Catalogue number Size Status
SR-0793-1415 In distribution
SR-1215-8511 In distribution
SR0040-11 In distribution
SR0040-12 In distribution
SR-1165 In distribution
SR0040-10 In distribution
SR-1215-8505 In distribution
SR0040-5 In distribution
SR-0426-09 In distribution
SR-0684 In distribution
SR-0426-10 In distribution
SR-1068-07 In distribution
SR-0793-1610 In distribution
SR-0793-1210 In distribution
SR-1215-4309 In distribution
SR-1068-06 In distribution
SR-1067-09 In distribution
SR-1067-05 In distribution
SR-1215-8509 In distribution
SR-1215-4305 In distribution
SR-1215-0512 In distribution
SR-0813-12 In distribution
SR-0590 In distribution
SR-1479 In distribution
SR-1215-4308 In distribution
SR-0437-05 In distribution
SR-1116-06 In distribution
SR-0793-1010 In distribution
SR0040-7 In distribution
SR-1116-08 In distribution
SR-0437-07 In distribution
SR-0437-06 In distribution
SR-1215-4307 In distribution
SR-0519 In distribution
SR-0813-08 In distribution
SR-1215-6412 In distribution
SR0040-8 In distribution
SR-1067-11 In distribution
SR-1068-10 In distribution
SR-1068-09 In distribution
SR-1215-4312 In distribution
SR-0813-05 In distribution
SR-0461 In distribution
SR-0437-09 In distribution
SR-0437-12 In distribution
SR-1480 In distribution
SR-0426-08 In distribution
SR-1215-8508 In distribution
SR-1215-8512 In distribution
SR-0676 In distribution
SR-1116-05 In distribution
SR-1215-4311 In distribution
SR-1116-11 In distribution
SR-0793-1410 In distribution
SR-0813-07 In distribution
SR-0518 In distribution
SR-1215-6407 In distribution
SR-0793-1215 In distribution
SR-1215-6405 In distribution
SR-1067-10 In distribution
SR-0426-12 In distribution
SR-0426-05 In distribution
SR-1215-0508 In distribution
SR-1068-11 In distribution
SR-1068-08 In distribution
SR-0529 In distribution
SR-0437-10 In distribution
SR-0813-09 In distribution
SR-0675 In distribution
SR0040-9 In distribution
SR-0437-08 In distribution
SR-1215-0510 In distribution
SR-1215-0509 In distribution
SR-1215-0507 In distribution
SR-1215-8506 In distribution
SR-1067-12 In distribution
SR-1097 In distribution
SR-0426-07 In distribution
SR0040-6 In distribution
SR-1215-6408 In distribution
SR-1215-4310 In distribution
SR-0437-11 In distribution
SR-0426-11 In distribution
SR-1116-12 In distribution
SR-1067-06 In distribution
SR-1215-8507 In distribution
SR-1067-07 In distribution
SR-1068-12 In distribution
SR-1096 In distribution
SR-0793-1615 In distribution
SR-1116-07 In distribution
SR-1215-0505 In distribution
SR-0426-06 In distribution
SR-0813-06 In distribution
SR-1215-8510 In distribution
SR-1215-0511 In distribution
SR-1215-0506 In distribution
SR-1116-10 In distribution
SR-1215-6410 In distribution
SR-1068-05 In distribution
SR-1215-6409 In distribution
SR-1215-4306 In distribution
SR-0495 In distribution
SR-1215-6411 In distribution
SR-1116-09 In distribution
SR-1067-08 In distribution
SR-0813-11 In distribution
SR-0813-10 In distribution
SR-1215-6406 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
Tranquil-C™ Nexus Spine, L.L.C. 158
Calix Spinal Implant System Xtant Medical Holdings, Inc. 143
Rasp Medtronic Sofamor Danek, Inc. 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