Dakota Alif System
36 X 28 X 15mm X 15° Trial Rasp
12manufacturers in China registered for this device type
43catalogue 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 | Precision Spine, Inc., United States |
|---|---|
| FDA product code | HTR |
| Device type | Rasp |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-03-28 |
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, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 69-RL-1515 | In distribution | |
| 69-RS-0019 | In distribution | |
| 69-RS-0813 | In distribution | |
| 69-RG-3019 | In distribution | |
| 69-RG-2019 | In distribution | |
| 69-RG-2517 | In distribution | |
| 69-RG-1515 | In distribution | |
| 69-RG-0811 | In distribution | |
| 69-RG-0813 | In distribution | |
| 69-RG-1519 | In distribution | |
| 69-RG-2515 | In distribution | |
| 69-RG-2017 | In distribution | |
| 69-RG-1511 | In distribution | |
| 69-RG-0817 | In distribution | |
| 69-RG-0019 | In distribution | |
| 69-RG-3017 | In distribution | |
| 69-RG-0815 | In distribution | |
| 69-RS-0017 | In distribution | |
| 69-RL-2519 | In distribution | |
| 69-RS-0011 | In distribution | |
| 69-RG-0819 | In distribution | |
| 69-RG-1517 | In distribution | |
| 69-RG-0011 | In distribution | |
| 69-RS-0811 | In distribution | |
| 69-RG-2519 | In distribution | |
| 69-RL-2017 | In distribution | |
| 69-RL-3019 | In distribution | |
| 69-RG-2015 | In distribution | |
| 69-RG-1513 | In distribution | |
| 69-RS-0013 | In distribution | |
| 69-RG-0015 | In distribution | |
| 69-RG-2013 | In distribution | |
| 69-RG-0017 | In distribution | |
| 69-RL-2013 | In distribution | |
| 69-RL-2015 | In distribution | |
| 69-RL-2019 | In distribution | |
| 69-RL-2517 | In distribution | |
| 69-RG-0013 | In distribution | |
| 69-RL-1519 | In distribution | |
| 69-RS-0015 | In distribution | |
| 69-RL-1517 | In distribution | |
| 69-RL-3017 | In distribution | |
| 69-RL-2515 | 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.