Blustone Synergy Cervical Trial (Slate)
The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that…
The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The cervical trials are available in 11mmX14mm and 13mmX17mm footprints, lordotic and parallel configurations, and thicknesses from 5mm to 11mm.
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 | Blustone Synergy, LLC, United States |
|---|---|
| FDA product code | HWT |
| Device type | Template |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4800 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2018-01-29 |
| Record revised | 2018-06-26 (version 3) |
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 |
| Sizes | Width 11 to 13 mm; height 5 to 11 mm; length 14 to 17 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9017-CTP05 | Width 13 mm | In distribution |
| 9014-CTP7 | Width 11 mm | In distribution |
| 9014-CTP6 | Width 11 mm | In distribution |
| 9014-CTL11 | Width 11 mm | In distribution |
| 9014-CTP5 | Width 11 mm | In distribution |
| 9014-CTL9 | Length 14 mm | In distribution |
| 9017-CTL11 | Width 13 mm | In distribution |
| 9014-CTL5 | Length 14 mm | In distribution |
| 9017-CTL06 | Width 13 mm | In distribution |
| 9014-CTL7 | Width 11 mm | In distribution |
| 9014-CTP10 | Width 11 mm | In distribution |
| 9014-CTL6 | Width 11 mm | In distribution |
| 9014-CTP9 | Width 11 mm | In distribution |
| 9017-CTL07 | Width 13 mm | In distribution |
| 9014-CTL10 | Width 11 mm | In distribution |
| 9017-CTP06 | Width 13 mm | In distribution |
| 9017-CTL05 | Width 13 mm | In distribution |
| 9014-CTP11 | Width 11 mm | In distribution |
| 9014-CTP8 | Width 11 mm | In distribution |
| 9017-CTP09 | Width 13 mm | In distribution |
| 9017-CTP07 | Width 13 mm | In distribution |
| 9017-CTP10 | Width 13 mm | In distribution |
| 9017-CTL10 | Width 13 mm | In distribution |
| 9017-CTL08 | Width 13 mm | In distribution |
| 9017-CTP11 | Width 13 mm | In distribution |
| 9014-CTL8 | Width 11 mm | In distribution |
| 9017-CTL09 | Width 13 mm | In distribution |
| 9017-CTP08 | Width 13 mm | 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.