Quantum

QUANTUM Tibial Stem Cruciform Guide Right Size 4

Registry build 21.09.26
21manufacturers in China registered for this device type
169catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Shanghai (3), Zhejiang (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWT
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Suzhou AND Science & Technology Development Corp. Zhangjiagang Jiangsu Contract manufacturer 5
Guangzhou Clean Medical Products Manufacturing Corp Guangzhou Guangdong Contract manufacturer 5
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235

Showing 12 of 21. All 21 manufacturers in China registered for Template

Record

Regulatory record for Quantum
Listed by In2Bones SAS, France
FDA product code HWT
Device type Template
Device class Class 1
Regulation 21 CFR 888.4800
Establishment Specification developer, Manufacturer, Exporter
510(k) K191380
Record published 2024-12-13
Record revised 2026-03-31 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Sizes Length 4 to 36 mm; height 5 to 11 mm; length 15.27 µm

Catalogue Numbers

Catalogue numbers for Quantum
Catalogue number Size Status
M05 00237 In distribution
M05 00233 In distribution
M05 00173 In distribution
M05 00272 In distribution
M05 00205 In distribution
M05 00181 Length 15.27 mm In distribution
M05 00041 Length 13.28 mm In distribution
M05 00221 Length 13.28 mm In distribution
M05 00206 In distribution
M05 00192 In distribution
M05 00225 In distribution
M05 00244 In distribution
M05 00242 In distribution
M05 00147 In distribution
M05 00531 In distribution
M05 00168 In distribution
M05 00187 In distribution
M05 00111 Length 14.25 mm In distribution
M05 00132 In distribution
M05 00421 In distribution
M05 00141 Length 11.61 mm In distribution
M05 00236 In distribution
M05 00162 In distribution
M05 00451 In distribution
M05 00248 In distribution
M05 00621 In distribution
M05 00234 In distribution
M05 00063 In distribution
M05 00091 Length 12.28 mm In distribution
M05 00243 In distribution
M05 00208 In distribution
M05 00361 In distribution
M05 00176 In distribution
M05 00215 In distribution
M05 00282 In distribution
M05 00271 Height 7 mm In distribution
M05 00246 In distribution
M05 00165 In distribution
M05 00043 In distribution
M05 00481 In distribution
M05 00172 In distribution
M05 00203 In distribution
M05 00461 In distribution
M05 00238 In distribution
M05 00042 In distribution
M05 00581 In distribution
M05 00157 In distribution
M05 00022 In distribution
M05 00145 In distribution
M05 00591 In distribution
M05 00241 Length 15.27 mm In distribution
M05 00641 In distribution
M05 00166 In distribution
M05 00231 Length 14.25 mm In distribution
M05 00441 In distribution
M05 00216 In distribution
M05 00023 In distribution
M05 00341 In distribution
M05 00262 In distribution
M05 00102 In distribution
M05 00253 In distribution
M05 00471 In distribution
M05 00061 Length 15.27 µm In distribution
M05 00052 In distribution
M05 00214 In distribution
M05 00311 In distribution
M05 00072 In distribution
M05 00228 In distribution
M05 00227 In distribution
M05 00391 In distribution
M05 00062 In distribution
M05 00213 In distribution
M05 00113 In distribution
M05 00071 Length 10.65 mm In distribution
M05 00131 Length 10.65 mm In distribution
M05 00171 Length 14.25 mm In distribution
M05 00161 Length 13.28 mm In distribution
M05 00092 In distribution
M05 00153 In distribution
M05 00571 In distribution
M05 00541 In distribution
M05 00164 In distribution
M05 00186 In distribution
M05 00144 In distribution
M05 00123 In distribution
M05 00174 In distribution
M05 00551 In distribution
M05 00151 Length 12.28 mm In distribution
M05 00101 Length 13.28 mm In distribution
M05 00146 In distribution
M05 00191 Length 10.65 mm In distribution
M05 00033 In distribution
M05 00411 In distribution
M05 00013 In distribution
M05 00211 Length 12.28 mm In distribution
M05 00178 In distribution
M05 00226 In distribution
M05 00155 In distribution
M05 00371 In distribution
M05 00154 In distribution
M05 00351 In distribution
M05 00401 In distribution
M05 00152 In distribution
M05 00232 In distribution
M05 00112 In distribution
M05 00021 Length 11.61 mm In distribution
M05 00051 Length 14.25 mm In distribution
M05 01262 In distribution
M05 00103 In distribution
M05 00224 In distribution
M05 00247 In distribution
M05 00093 In distribution
M05 00301 In distribution
M05 00252 In distribution
M05 00561 In distribution
M05 00122 In distribution
M05 00156 In distribution
M05 00501 In distribution
M05 00175 In distribution
M05 00185 In distribution
M05 00011 Length 10.65 mm In distribution
M05 00281 Height 8 mm In distribution
M05 00251 Height 5 mm In distribution
M05 00631 In distribution
M05 00184 In distribution
M05 00204 In distribution
M05 00431 In distribution
M05 00177 In distribution
M05 00121 Length 15.27 mm In distribution
M05 00331 In distribution
M05 00245 In distribution
M05 00511 In distribution
M05 00207 In distribution
M05 00188 In distribution
M05 00082 In distribution
M05 00201 Length 11.61 mm In distribution
M05 00163 In distribution
M05 00148 In distribution
M05 00158 In distribution
M05 00167 In distribution
M05 00217 In distribution
M05 00292 In distribution
M05 00212 In distribution
M05 00073 In distribution
M05 00321 In distribution
M05 00183 In distribution
M05 00491 In distribution
M05 00235 In distribution
M05 00081 Length 11.61 mm In distribution
M05 00222 In distribution
M05 00143 In distribution
M05 00218 In distribution
M05 00142 In distribution
M05 00261 Height 6 mm In distribution
M05 00031 Length 12.28 mm In distribution
M05 00651 In distribution
M05 00053 In distribution
M05 00083 In distribution
M05 00611 In distribution
M05 00032 In distribution
M05 00291 Height 9 mm In distribution
M05 00012 In distribution
M05 01261 Height 11 mm In distribution
M05 00381 In distribution
M05 00182 In distribution
M05 00202 In distribution
M05 00521 In distribution
M05 00223 In distribution
M05 00601 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Attune Depuy (Ireland) 1,385
Template Exactech, Inc. 1,277
4WEB Medical 4WEB Inc. 991
Evolution® Microport Orthopedics Inc. 966
Template Zimmer, Inc. 792
Advance® Microport Orthopedics Inc. 644
Apex Knee System Omni Life Science, Inc. 635
Profemur® Microport Orthopedics Inc. 591
Link Instruments – Trial implants and size gauges Waldemar Link GmbH & Co. KG 549
Template Synthes Gmbh 516
Optetrak Logic Exactech, Inc. 512
Template Depuy Spine, Inc. 451

Showing 12 of 2,940. All products under Template

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