Link Instruments – Rasps, Compressors and Broaches
Medullary canal orthopaedic reamer, rigid - Gemini SL Total Knee System
12manufacturers in China registered for this device type
83catalogue 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 | Waldemar Link GmbH & Co. KG, Germany |
|---|---|
| FDA product code | HTR |
| Device type | Rasp |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-19 |
| Record revised | 2024-08-15 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 130-550/07 | In distribution | |
| 130-552/06 | In distribution | |
| 130-553/02 | In distribution | |
| 130-553/03 | In distribution | |
| 130-552/01 | In distribution | |
| 130-950/60 | In distribution | |
| 99-0039/74 | In distribution | |
| 130-940/65 | In distribution | |
| 130-942/60 | In distribution | |
| 130-948/61 | In distribution | |
| 130-551/01 | In distribution | |
| 130-555/04 | In distribution | |
| 130-553/06 | In distribution | |
| 130-550/03 | In distribution | |
| 130-551/07 | In distribution | |
| 99-0039/78 | In distribution | |
| 99-0039/77 | In distribution | |
| 99-0039/69 | In distribution | |
| 130-550/04 | In distribution | |
| 130-554/03 | In distribution | |
| 130-553/01 | In distribution | |
| 130-555/05 | In distribution | |
| 130-940/60 | In distribution | |
| 130-555/03 | In distribution | |
| 130-554/01 | In distribution | |
| 130-555/02 | In distribution | |
| 130-550/01 | In distribution | |
| 130-955/60 | In distribution | |
| 130-552/07 | In distribution | |
| 130-955/65 | In distribution | |
| 130-946/60 | In distribution | |
| 130-553/07 | In distribution | |
| 130-953/60 | In distribution | |
| 130-552/03 | In distribution | |
| 130-957/65 | In distribution | |
| 99-0039/75 | In distribution | |
| 130-941/65 | In distribution | |
| 130-949/60 | In distribution | |
| 130-949/61 | In distribution | |
| 130-555/01 | In distribution | |
| 130-550/02 | In distribution | |
| 130-944/60 | In distribution | |
| 99-0039/73 | In distribution | |
| 130-552/04 | In distribution | |
| 99-0039/72 | In distribution | |
| 99-0039/80 | In distribution | |
| 99-0039/68 | In distribution | |
| 99-0039/70 | In distribution | |
| 130-943/60 | In distribution | |
| 130-551/05 | In distribution | |
| 130-947/60 | In distribution | |
| 130-554/04 | In distribution | |
| 130-956/65 | In distribution | |
| 130-555/07 | In distribution | |
| 130-553/05 | In distribution | |
| 130-952/60 | In distribution | |
| 130-550/05 | In distribution | |
| 130-554/02 | In distribution | |
| 130-554/06 | In distribution | |
| 99-0039/79 | In distribution | |
| 130-550/06 | In distribution | |
| 130-552/02 | In distribution | |
| 130-552/05 | In distribution | |
| 99-0039/81 | In distribution | |
| 130-951/60 | In distribution | |
| 130-948/60 | In distribution | |
| 130-945/60 | In distribution | |
| 319-260/00 | In distribution | |
| 130-554/05 | In distribution | |
| 99-0039/71 | In distribution | |
| 130-957/60 | In distribution | |
| 130-956/60 | In distribution | |
| 130-943/65 | In distribution | |
| 130-555/06 | In distribution | |
| 130-553/04 | In distribution | |
| 130-551/03 | In distribution | |
| 130-554/07 | In distribution | |
| 130-942/65 | In distribution | |
| 130-551/06 | In distribution | |
| 130-551/04 | In distribution | |
| 130-941/60 | In distribution | |
| 99-0039/76 | In distribution | |
| 130-551/02 | 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 |
| 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.