Medtronic Reusable Instruments

Rasp EX1023212 LS Small 12DEG 32X25X12MM

Registry build 21.09.26
12manufacturers in China registered for this device type
240catalogue 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 Medtronic Reusable Instruments
Listed by Medtronic Sofamor Danek, Inc., United States
FDA product code HTR
Device type Rasp
Device class Class 1
Regulation 21 CFR 878.4800
Premarket notification Exempt
Record published 2022-10-07
Record revised 2022-06-10 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Over the counter Yes
Label carries lot or batch number
Distribution end date 2026-04-27
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Medtronic Reusable Instruments
Catalogue number Size Status
EX0113017 In distribution
EX0211334 In distribution
EX0411054 In distribution
EX0411053 In distribution
EX0821005 In distribution
EX1023112 In distribution
EX1023212 In distribution
975-244 In distribution
EX0821006 In distribution
EX1110245 In distribution
EX1110246 In distribution
X0198-006 In distribution
EX0112168 In distribution
EX0211328 In distribution
X0226019 In distribution
X0404005 In distribution
EX1222009 In distribution
8750911 In distribution
X0226033 In distribution
6971387 In distribution
EX0411044 In distribution
Y875-747 In distribution
EX0821004 In distribution
EX0211327 In distribution
EX0411066 In distribution
X0604036 In distribution
EX0411048 In distribution
6971368 In distribution
EX0322011 In distribution
975-544 In distribution
Y875-743 In distribution
Y875-742 In distribution
X9751141 In distribution
X0604037 In distribution
EX1111609 In distribution
8750844 In distribution
174-883 In distribution
Y875-748 In distribution
EX0222002 In distribution
EX0711036 In distribution
X0404008 In distribution
EX0222011 In distribution
EX0211335 In distribution
X0198-008 In distribution
EX0411058 In distribution
X0404010 In distribution
9198240 In distribution
X0226030 In distribution
EX1018001 In distribution
EX0222003 In distribution
EX0222009 In distribution
EX0411046 In distribution
8750511 In distribution
6971348 In distribution
X0226025 In distribution
EX0211161 In distribution
X0995-900 In distribution
EX1010925 In distribution
EX0411065 In distribution
EX0211325 In distribution
EX0219056 In distribution
EX0222007 In distribution
EX0119022 In distribution
8750744 In distribution
EX0211322 In distribution
EX0911189 In distribution
EX1010926 In distribution
8750944 In distribution
Y875-746 In distribution
975-344 In distribution
X0404006 In distribution
EX0211329 In distribution
X0226034 In distribution
EX0911181 In distribution
EX1018003 In distribution
EX0411062 In distribution
X0404009 In distribution
EX0322010 In distribution
975-044 In distribution
EX0211336 In distribution
EX0222006 In distribution
EX0211326 In distribution
X0198-007 In distribution
8750111 In distribution
EX0211320 In distribution
EX0211323 In distribution
EX0411045 In distribution
EX0411059 In distribution
EX0222005 In distribution
EX0411056 In distribution
EX1210209 In distribution
8750611 In distribution
975-844 In distribution
X0226020 In distribution
EX0411064 In distribution
X0404007 In distribution
6971366 In distribution
EX1211052 In distribution
X0811305 In distribution
X0811307 In distribution
EX0121061 In distribution
EX0211321 In distribution
EX0911188 In distribution
EX1210210 In distribution
EX1017021 In distribution
X9750941 In distribution
Y875-740 In distribution
975-144 In distribution
EX0119023 In distribution
975-744 In distribution
X0518047 In distribution
6971388 In distribution
EX1023110 In distribution
EX0911182 In distribution
X0404012 In distribution
8750011 In distribution
6971345 In distribution
X0811306 In distribution
EX1110247 In distribution
EX1010923 In distribution
EX0211333 In distribution
6971347 In distribution
EX0121062 In distribution
8750544 In distribution
X0226026 In distribution
EX0211337 In distribution
EX0222008 In distribution
EX0113020 In distribution
8750244 In distribution
EX09103861 In distribution
EX0222012 In distribution
EX0119021 In distribution
X0226032 In distribution
EX0211339 In distribution
EX0211340 In distribution
EX0411052 In distribution
EX0821003 In distribution
EX0222010 In distribution
EX0411060 In distribution
X0617015 In distribution
EX0119020 In distribution
EX0211324 In distribution
EX0211207 In distribution
X0226024 In distribution
EX0311012 In distribution
X0226029 In distribution
X9751341 In distribution
EX1018002 In distribution
EX0411061 In distribution
EX0312004 In distribution
X9751241 In distribution
8750711 In distribution
EX0114071 In distribution
EX0411051 In distribution
EX0411067 In distribution
8750811 In distribution
6971365 In distribution
EX0821002 In distribution
X9751041 In distribution
X0604039 In distribution
EX1211019 In distribution
X0902018 In distribution
EX0222004 In distribution
EX0211332 In distribution
X0226028 In distribution
EX1112010 In distribution
EX0411047 In distribution
EX0411050 In distribution
EX0411063 In distribution
EX0312005 In distribution
EX0911190 In distribution
8750644 In distribution
Y875-741 In distribution
EX1017020 In distribution
EX1023210 In distribution
EX1017019 In distribution
EX0119024 In distribution
X0226023 In distribution
EX0917025 In distribution
975-644 In distribution
EX0222013 In distribution
EX0412158 In distribution
EX1211053 In distribution
EX1211054 In distribution
6971326 In distribution
975-944 In distribution
EX0311007 In distribution
EX0911180 In distribution
EX0113018 In distribution
EX1121014 In distribution
EX0113127 In distribution
EX0211338 In distribution
EX0211331 In distribution
X9750541 In distribution
EX1010924 In distribution
EX0222014 In distribution
EX0322012 In distribution
6971327 In distribution
EX0219054 In distribution
X9750641 In distribution
X0604040 In distribution
EX0411049 In distribution
EX0113016 In distribution
EX0420050 In distribution
X0604035 In distribution
6971346 In distribution
X0226027 In distribution
X0604038 In distribution
EX0411055 In distribution
EX0910044 In distribution
8750044 In distribution
EX0211206 In distribution
EX0211330 In distribution
X0595-012 In distribution
X0404011 In distribution
EX0219055 In distribution
X0707110 In distribution
X0902019 In distribution
EX0111008 In distribution
EX0411057 In distribution
X0226031 In distribution
Y875-745 In distribution
X0604041 In distribution
X0411356 Withdrawn
YIB0801-051 Withdrawn
X0411358 Withdrawn
X0213185 Withdrawn
X0411348 Withdrawn
X0411354 Withdrawn
X9750741 Withdrawn
X0411350 Withdrawn
X0310678 Withdrawn
X0411352 Withdrawn
X0310680 Withdrawn
X0213186 Withdrawn
X0213187 Withdrawn
X0213184 Withdrawn
X0310679 Withdrawn
X9750841 Withdrawn
X0213183 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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
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