Mergence-S Spinal Instrumentation System
Parallel Rasp
12manufacturers in China registered for this device type
28catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (4), Guangdong (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 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Shenzhen Xiazhifeng Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 25 |
Record
| Listed by | Highridge Medical, LLC, United States |
|---|---|
| FDA product code | HTR |
| Device type | Rasp |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-11-16 |
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, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 96-108-57081 | In distribution | |
| 96-108-60121 | In distribution | |
| 96-108-50041 | In distribution | |
| 96-108-60071 | In distribution | |
| 96-108-50051 | In distribution | |
| 96-108-60041 | In distribution | |
| 96-108-57101 | In distribution | |
| 96-108-57121 | In distribution | |
| 96-108-47121 | In distribution | |
| 96-108-50081 | In distribution | |
| 96-108-50071 | In distribution | |
| 96-108-57091 | In distribution | |
| 96-108-60051 | In distribution | |
| 96-108-57041 | In distribution | |
| 96-108-60111 | In distribution | |
| 96-108-60101 | In distribution | |
| 96-108-50101 | In distribution | |
| 96-108-47101 | In distribution | |
| 96-108-50061 | In distribution | |
| 96-108-57111 | In distribution | |
| 96-108-60091 | In distribution | |
| 96-108-50091 | In distribution | |
| 96-108-60061 | In distribution | |
| 96-108-60081 | In distribution | |
| 96-108-50111 | In distribution | |
| 96-108-57071 | In distribution | |
| 96-108-57051 | In distribution | |
| 96-108-47111 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 240 |
| TiWAVE C Cervical Cage System | Kalitec Direct, LLC | 232 |
| Tranquil-C™ | Nexus Spine, L.L.C. | 158 |
| Calix Spinal Implant System | Xtant Medical Holdings, Inc. | 143 |
| Rasp | Medtronic Sofamor Danek, Inc. | 109 |
| Specials | Seaspine Orthopedics Corporation | 109 |
| Stryker | Avalign Technologies, Inc. | 105 |
| Endoskeleton® TAS | Medtronic Sofamor Danek, Inc. | 93 |
| Intervertebral Disc Preparation Instruments | Alphatec Spine, Inc. | 90 |
| Cambria | Seaspine Orthopedics Corporation | 85 |
| IdentiTi | Alphatec Spine, Inc. | 83 |
| Link Instruments – Rasps, compressors and broaches | Waldemar Link GmbH & Co. KG | 83 |
Showing 12 of 378. All products under Rasp
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.