Columbus Revision F
COL REV Trial HEMI-SPCR.T4/4+ 10MM RM/LL
21manufacturers in China registered for this device type
57catalogue numbers in this listing
2recalls on this code
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 | Aesculap AG, Germany |
|---|---|
| FDA product code | HWT |
| Device type | Template |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-05-08 |
| Record revised | 2025-11-13 (version 7) |
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 |
| Distribution end date | 2025-10-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NP052M | Withdrawn | |
| NP041M | Withdrawn | |
| NP070M | Withdrawn | |
| NP081M | Withdrawn | |
| NP096M | Withdrawn | |
| NP105 | Withdrawn | |
| NP076M | Withdrawn | |
| NP080M | Withdrawn | |
| NP056M | Withdrawn | |
| NP059 | Withdrawn | |
| NS127R | Withdrawn | |
| NS127 | Withdrawn | |
| NS122 | Withdrawn | |
| NP087M | Withdrawn | |
| NP089 | Withdrawn | |
| NS122R | Withdrawn | |
| NP077M | Withdrawn | |
| NP099 | Withdrawn | |
| NS123R | Withdrawn | |
| NP062M | Withdrawn | |
| NP041 | Withdrawn | |
| NP098M | Withdrawn | |
| NP097M | Withdrawn | |
| NS131R | Withdrawn | |
| NP050M | Withdrawn | |
| NP051M | Withdrawn | |
| NS120 | Withdrawn | |
| NP061M | Withdrawn | |
| NP040M | Withdrawn | |
| NS126R | Withdrawn | |
| NS120R | Withdrawn | |
| NS126 | Withdrawn | |
| NP082M | Withdrawn | |
| NP040 | Withdrawn | |
| NP069 | Withdrawn | |
| NP079 | Withdrawn | |
| NP092M | Withdrawn | |
| NP066M | Withdrawn | |
| NS124 | Withdrawn | |
| NP086M | Withdrawn | |
| NP072M | Withdrawn | |
| NS124R | Withdrawn | |
| NP106 | Withdrawn | |
| NP060M | Withdrawn | |
| NP061 | Withdrawn | |
| NP049 | Withdrawn | |
| NS123 | Withdrawn | |
| NP090M | Withdrawn | |
| NP091M | Withdrawn | |
| NP062 | Withdrawn | |
| NP046 | Withdrawn | |
| NP042 | Withdrawn | |
| NP042M | Withdrawn | |
| NP067M | Withdrawn | |
| NP071M | Withdrawn | |
| NP088M | Withdrawn | |
| NP046M | Withdrawn |
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
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-08-10 | Class II | Mixed-up of materials/components | The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size trial is used the potential risk is implantation of the incorrect implant size which may lead to injury of ligaments, pain and pos | 13 Units | 2018-08-08 |
| 2012-07-12 | Class II | Employee error | The 4 degree and 9 degree trial instruments (SJ768T-US/SJ780T-US) are correctly dimensioned, but the part number etched on the instrument may be incorrect. The 4 degree trial instrument (SJ768T-US) may be marked with the incorrect part num | 5 | 2013-02-22 |
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.