Sigma
Sigma High Performance Fixed Reference Posterior Rotation Guide 0 DEG
21manufacturers in China registered for this device type
296catalogue 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 | Depuy (Ireland), Ireland |
|---|---|
| FDA product code | HWT |
| Device type | Template |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
| Record revised | 2026-05-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Distribution end date | 2024-10-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9505-02-142 | In distribution | |
| 96-3354 | In distribution | |
| 2011-03-009 | In distribution | |
| 2024-11-609 | In distribution | |
| 9505-02-148 | In distribution | |
| 96-3156 | In distribution | |
| 2024-07-200 | In distribution | |
| 2024-08-100 | In distribution | |
| 97-2355 | In distribution | |
| 97-2334 | In distribution | |
| 96-3355 | In distribution | |
| 9505-02-505 | In distribution | |
| 2960-91-250 | In distribution | |
| 2024-11-311 | In distribution | |
| 9505-02-040 | In distribution | |
| 9505-01-211 | In distribution | |
| 96-3361 | In distribution | |
| 96-3333 | In distribution | |
| 9505-02-111 | In distribution | |
| 96-3165 | In distribution | |
| 2011-03-022 | In distribution | |
| 86-6599 | In distribution | |
| 9505-02-102 | In distribution | |
| 2024-11-608 | In distribution | |
| 96-3363 | In distribution | |
| 9505-02-107 | In distribution | |
| 96-3345 | In distribution | |
| 97-2351 | In distribution | |
| 97-2333 | In distribution | |
| 9505-01-209 | In distribution | |
| 97-2371 | In distribution | |
| 86-6501 | In distribution | |
| 2024-72-600 | In distribution | |
| 96-3332 | In distribution | |
| 9505-01-271 | In distribution | |
| 9505-02-042 | In distribution | |
| 96-3365 | In distribution | |
| 2024-11-108 | In distribution | |
| 2024-08-600 | In distribution | |
| 2011-03-017 | In distribution | |
| 2024-72-500 | In distribution | |
| 9505-01-242 | In distribution | |
| 96-3136 | In distribution | |
| 96-1780 | In distribution | |
| 86-6568 | In distribution | |
| 9505-01-239 | In distribution | |
| 9505-01-264 | In distribution | |
| 2024-71-100 | In distribution | |
| 97-2364 | In distribution | |
| 2024-11-410 | In distribution | |
| 2024-11-407 | In distribution | |
| 2960-91-400 | In distribution | |
| 96-3316 | In distribution | |
| 2024-11-510 | In distribution | |
| 96-3356 | In distribution | |
| 9505-02-502 | In distribution | |
| 96-3312 | In distribution | |
| 2024-07-300 | In distribution | |
| 96-3115 | In distribution | |
| 97-2330 | In distribution | |
| 2960-81-300 | In distribution | |
| 96-1779 | In distribution | |
| 97-2324 | In distribution | |
| 97-2365 | In distribution | |
| 96-3368 | In distribution | |
| 96-3362 | In distribution | |
| 97-2340 | In distribution | |
| 96-1777 | In distribution | |
| 96-3126 | In distribution | |
| 96-3331 | In distribution | |
| 2024-11-610 | In distribution | |
| 96-3347 | In distribution | |
| 96-3314 | In distribution | |
| 97-2322 | In distribution | |
| 96-3167 | In distribution | |
| 2960-91-350 | In distribution | |
| 2024-11-310 | In distribution | |
| 96-1778 | In distribution | |
| 2024-11-508 | In distribution | |
| 2011-03-007 | In distribution | |
| 2024-85-007 | In distribution | |
| 9505-02-141 | In distribution | |
| 2960-91-300 | In distribution | |
| 2024-11-208 | In distribution | |
| 9505-01-275 | In distribution | |
| 96-1774 | In distribution | |
| 9505-02-146 | In distribution | |
| 2011-03-006 | In distribution | |
| 86-6569 | In distribution | |
| 2024-71-600 | In distribution | |
| 2024-07-500 | In distribution | |
| 96-3117 | In distribution | |
| 96-3146 | In distribution | |
| 96-3323 | In distribution | |
| 9505-02-506 | In distribution | |
| 2011-03-057 | In distribution | |
| 2024-72-300 | In distribution | |
| 2024-50-011 | In distribution | |
| 2011-03-020 | In distribution | |
| 96-3311 | In distribution | |
| 2024-85-003 | In distribution | |
| 9505-02-046 | In distribution | |
| 2960-81-350 | In distribution | |
| 96-3346 | In distribution | |
| 97-2383 | In distribution | |
| 96-3125 | In distribution | |
| 96-3166 | In distribution | |
| 96-3326 | In distribution | |
| 9505-02-110 | In distribution | |
| 2024-56-111 | In distribution | |
| 96-3321 | In distribution | |
| 96-3341 | In distribution | |
| 2024-11-211 | In distribution | |
| 96-3317 | In distribution | |
| 9505-01-263 | In distribution | |
| 2011-03-014 | In distribution | |
| 96-3348 | In distribution | |
| 2024-50-010 | In distribution | |
| 2024-41-500 | In distribution | |
| 9505-01-121 | In distribution | |
| 97-2320 | In distribution | |
| 97-2385 | In distribution | |
| 9505-01-273 | In distribution | |
| 9505-02-503 | In distribution | |
| 2960-81-500 | In distribution | |
| 96-3315 | In distribution | |
| 96-3351 | In distribution | |
| 2011-03-012 | In distribution | |
| 97-2343 | In distribution | |
| 97-2342 | In distribution | |
| 2024-11-511 | In distribution | |
| 96-3367 | In distribution | |
| 96-3116 | In distribution | |
| 2024-11-308 | In distribution | |
| 2024-11-607 | In distribution | |
| 96-3358 | In distribution | |
| 2024-72-400 | In distribution | |
| 97-2341 | In distribution | |
| 9505-02-504 | In distribution | |
| 9505-01-276 | In distribution | |
| 9505-01-302 | In distribution | |
| 2024-43-304 | In distribution | |
| 97-2372 | In distribution | |
| 2024-11-209 | In distribution | |
| 96-3338 | In distribution | |
| 2024-08-500 | In distribution | |
| 9505-01-266 | In distribution | |
| 97-2345 | In distribution | |
| 9505-01-277 | In distribution | |
| 9505-02-106 | In distribution | |
| 96-2777 | In distribution | |
| 96-3328 | In distribution | |
| 96-3344 | In distribution | |
| 97-2335 | In distribution | |
| 2011-03-023 | In distribution | |
| 2024-50-001 | In distribution | |
| 2024-11-409 | In distribution | |
| 2011-03-013 | In distribution | |
| 97-2381 | In distribution | |
| 2024-71-500 | In distribution | |
| 2024-72-200 | In distribution | |
| 9505-01-235 | In distribution | |
| 2960-91-200 | In distribution | |
| 9505-02-100 | In distribution | |
| 96-3364 | In distribution | |
| 2960-81-600 | In distribution | |
| 9505-02-147 | In distribution | |
| 97-2353 | In distribution | |
| 2024-43-102 | In distribution | |
| 9505-01-247 | In distribution | |
| 96-3324 | In distribution | |
| 96-3155 | In distribution | |
| 9505-02-101 | In distribution | |
| 9505-02-108 | In distribution | |
| 2011-03-015 | In distribution | |
| 96-3336 | In distribution | |
| 9505-01-272 | In distribution | |
| 96-3145 | In distribution | |
| 97-2350 | In distribution | |
| 2960-81-150 | In distribution | |
| 2024-85-002 | In distribution | |
| 2024-11-109 | In distribution | |
| 2024-11-111 | In distribution | |
| 2960-91-100 | In distribution | |
| 2024-08-200 | In distribution | |
| 2024-11-309 | In distribution | |
| 9505-02-507 | In distribution | |
| 9505-02-044 | In distribution | |
| 2960-81-250 | In distribution | |
| 2024-71-300 | In distribution | |
| 97-2323 | In distribution | |
| 2024-11-408 | In distribution | |
| 9505-01-269 | In distribution | |
| 2011-03-051 | In distribution | |
| 96-3337 | In distribution | |
| 2011-03-018 | In distribution | |
| 9505-01-270 | In distribution | |
| 96-3313 | In distribution | |
| 97-2363 | In distribution | |
| 97-2344 | In distribution | |
| 2024-85-006 | In distribution | |
| 9505-02-105 | In distribution | |
| 2960-81-200 | In distribution | |
| 97-2332 | In distribution | |
| 96-3325 | In distribution | |
| 97-2375 | In distribution | |
| 9505-02-501 | In distribution | |
| 2024-45-111 | In distribution | |
| 97-2374 | In distribution | |
| 96-3318 | In distribution | |
| 2960-91-150 | In distribution | |
| 2024-11-507 | In distribution | |
| 2011-03-021 | In distribution | |
| 2024-47-506 | In distribution | |
| 97-2384 | In distribution | |
| 2024-11-207 | In distribution | |
| 97-2382 | In distribution | |
| 96-3137 | In distribution | |
| 96-3342 | In distribution | |
| 2960-81-400 | In distribution | |
| 9505-02-112 | In distribution | |
| 96-3135 | In distribution | |
| 2024-11-611 | In distribution | |
| 2024-11-210 | In distribution | |
| 9505-01-190 | In distribution | |
| 9505-02-109 | In distribution | |
| 2024-47-102 | In distribution | |
| 2011-03-019 | In distribution | |
| 2024-11-307 | In distribution | |
| 9505-01-267 | In distribution | |
| 9505-02-143 | In distribution | |
| 9505-01-274 | In distribution | |
| 97-2361 | In distribution | |
| 9505-02-508 | In distribution | |
| 97-2362 | In distribution | |
| 96-3147 | In distribution | |
| 96-3327 | In distribution | |
| 2011-03-024 | In distribution | |
| 9505-01-243 | In distribution | |
| 2024-07-100 | In distribution | |
| 97-2354 | In distribution | |
| 96-3335 | In distribution | |
| 2024-47-304 | In distribution | |
| 9505-02-045 | In distribution | |
| 96-3353 | In distribution | |
| 9505-01-268 | In distribution | |
| 9505-02-145 | In distribution | |
| 2004-20-926 | In distribution | |
| 2011-03-008 | In distribution | |
| 2011-03-061 | In distribution |
Showing 250 of 296 catalogue numbers.
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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.