Blustone Synergy Lumbar Plif Inserter (Basalt)
The BluStone Synergy Basalt System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM…
The BluStone Synergy Basalt 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 Basalt PLIF implant inserter is designed to allow for disassembly during cleaning and sterilization. Instructions regarding disassembly, cleaning and sterilization of the inserter/pusher instrument are provided in the product insert.
Who Else Makes It
Concentrated in Jiangsu (10), Zhejiang (5), Guangdong (4). 14 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 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | 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 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
Showing 12 of 26. All 26 manufacturers in China registered for Guide, Surgical, Instrument
Record
| Listed by | Blustone Synergy, LLC, United States |
|---|---|
| FDA product code | FZX |
| Device type | Guide, Surgical, Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2018-01-29 |
| Record revised | 2024-09-11 (version 6) |
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 | Length 9.89 in; lumen/inner diameter 0.201 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9200-PI01 | Length 9.89 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DJO Surgical | Encore Medical, L.P. | 2,141 |
| Guide, Surgical, Instrument | Synthes Gmbh | 727 |
| DJO Surgical | DJO, LLC | 284 |
| Apex Knee System | Omni Life Science, Inc. | 272 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 223 |
| Motoband CP | Crossroads Extremity Systems LLC | 221 |
| Advance® | Microport Orthopedics Inc. | 199 |
| NexGen® | Zimmer, Inc. | 194 |
| Evolution® | Microport Orthopedics Inc. | 173 |
| Innomed, Inc. | Innomed, Inc. | 172 |
| Newclip Instruments | Newclip Technics SAS | 144 |
| Guide, Surgical, Instrument | Zimmer, Inc. | 135 |
Showing 12 of 1,788. All products under Guide, Surgical, Instrument
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.