Quantum
QUANTUM Tibial Stem Cruciform Guide Right Size 4
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.
| 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
| 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
| 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 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
| 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.