Fusion™ Posterior Instrument Set
4 catalogue numbers from 30-BOXCHISEL-8, listed by Xtant Medical Holdings, Inc., United States, under Chisel, Surgical, Manual. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Zhejiang (3), Jiangsu (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
Record
| Listed by | Xtant Medical Holdings, Inc., United States |
|---|---|
| FDA product code | FZO |
| Device type | Chisel, Surgical, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-30 |
| Record revised | 2025-11-14 (version 5) |
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 |
| Distribution end date | 2023-02-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30-BOXCHISEL-8 | Withdrawn | |
| 30-BOXCHISEL-10 | Withdrawn | |
| 30-BOXCHISEL-12 | Withdrawn | |
| 30-BOXCHISEL-14 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surtex | Surtex Instruments Ltd | 297 |
| Sklar | Sklar Corporation | 175 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 119 |
| Timberline Lateral Fusion System | Highridge Medical, LLC | 96 |
| Ambler Surgical | Ambler Surgical, LLC | 95 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 87 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 60 |
| Boss Instruments | Boss Instruments, Ltd. | 52 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 50 |
| Aesculap | Aesculap AG | 42 |
| Kmedic | Teleflex Medical LLC | 41 |
| American Medicals | American Medicals | 41 |
Showing 12 of 179. All products under Chisel, Surgical, Manual
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.