Stryker
18mm X 31mm X 36mm X 10 degrees Rasp Trial
12manufacturers in China registered for this device type
105catalogue 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 | Avalign Technologies, Inc., 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 | 2020-08-11 |
| Record revised | 2024-01-23 (version 4) |
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 |
| Distribution end date | 2023-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 480148161 | In distribution | |
| 480142401 | In distribution | |
| 480142863 | In distribution | |
| 480144161 | In distribution | |
| 480146405 | In distribution | |
| 480140162 | In distribution | |
| 480148165 | In distribution | |
| 480142860 | In distribution | |
| 480140861 | In distribution | |
| 480140532 | In distribution | |
| 480141401 | In distribution | |
| 480144865 | In distribution | |
| 480148405 | In distribution | |
| 480144403 | In distribution | |
| 480148162 | In distribution | |
| 480146861 | In distribution | |
| 480148862 | In distribution | |
| 480144860 | In distribution | |
| 480144861 | In distribution | |
| 480140400 | In distribution | |
| 480142103 | In distribution | |
| 480140531 | In distribution | |
| 480148860 | In distribution | |
| 480144401 | In distribution | |
| 480142861 | In distribution | |
| 480140863 | In distribution | |
| 480141861 | In distribution | |
| 480142535 | In distribution | |
| 480130402 | In distribution | |
| 480144405 | In distribution | |
| 480146535 | In distribution | |
| 480142402 | In distribution | |
| 480144101 | In distribution | |
| 480146530 | In distribution | |
| 480142100 | In distribution | |
| 48970057 | In distribution | |
| 480141161 | In distribution | |
| 480146161 | In distribution | |
| 480140860 | In distribution | |
| 480148400 | In distribution | |
| 480140405 | In distribution | |
| 480142105 | In distribution | |
| 480144165 | In distribution | |
| 480148101 | In distribution | |
| 480146105 | In distribution | |
| 480148100 | In distribution | |
| 480149161 | In distribution | |
| 480140163 | In distribution | |
| 480130400 | In distribution | |
| 480148865 | In distribution | |
| 480142865 | In distribution | |
| 480148535 | In distribution | |
| 480149861 | In distribution | |
| 480142165 | In distribution | |
| 480144105 | In distribution | |
| 480144530 | In distribution | |
| 480148530 | In distribution | |
| 480146100 | In distribution | |
| 480146400 | In distribution | |
| 480146860 | In distribution | |
| 480140862 | In distribution | |
| 480132402 | In distribution | |
| 480146101 | In distribution | |
| 480149531 | In distribution | |
| 480142161 | In distribution | |
| 480149401 | In distribution | |
| 480148531 | In distribution | |
| 480141101 | In distribution | |
| 480148401 | In distribution | |
| 480146401 | In distribution | |
| 480140161 | In distribution | |
| 480148861 | In distribution | |
| 480134403 | In distribution | |
| 480146531 | In distribution | |
| 480146532 | In distribution | |
| 480140101 | In distribution | |
| 480146165 | In distribution | |
| 480148160 | In distribution | |
| 48970056 | In distribution | |
| 480148533 | In distribution | |
| 480140530 | In distribution | |
| 480146160 | In distribution | |
| 480140401 | In distribution | |
| 480148105 | In distribution | |
| 480140160 | In distribution | |
| 480148532 | In distribution | |
| 480140100 | In distribution | |
| 480140402 | In distribution | |
| 480142531 | In distribution | |
| 480141531 | In distribution | |
| 480140165 | In distribution | |
| 480140865 | In distribution | |
| 480146865 | In distribution | |
| 480144531 | In distribution | |
| 480142862 | In distribution | |
| 480149101 | In distribution | |
| 480140102 | In distribution | |
| 480142101 | In distribution | |
| 480144535 | In distribution | |
| 480142102 | In distribution | |
| 480140105 | In distribution | |
| 480140533 | In distribution | |
| 480140535 | In distribution | |
| 48970056S | Withdrawn | |
| 48970057S | Withdrawn |
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 |
| 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 |
| Rasp | Zimmer, Inc. | 77 |
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.