Mega Plus MIS Spine System
Catalogue number 11170, listed by BK Meditech Co., Ltd., South Korea, under Awl. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (3), Shandong (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 |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| 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 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
Showing 12 of 13. All 13 manufacturers in China registered for Awl
Record
| Listed by | BK Meditech Co., Ltd., South Korea |
|---|---|
| FDA product code | HWJ |
| Device type | Awl |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-14 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11170 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 91 |
| HNM Medical | HNM Stainless, LLC. | 42 |
| Awl | Synthes Gmbh | 41 |
| General Instruments | Alphatec Spine, Inc. | 36 |
| Alta Acdf System | Highridge Medical, LLC | 34 |
| Awl | Depuy Spine, Inc. | 30 |
| Brickyard Stand-Alone Alif | Altus Spine | 28 |
| Generic Surgical Instruments | CTL Medical Corporation | 26 |
| IdentiTi | Alphatec Spine, Inc. | 23 |
| Indy Standalone | Altus Spine | 23 |
| Invictus | Alphatec Spine, Inc. | 22 |
| Tecomet | Tecomet, Inc. | 21 |
Showing 12 of 480. All products under Awl
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.