Link Instruments – Alignment and Positioning Instruments
Orthopaedic prosthesis implantation instrument, reusable - LINK SLED Prosthesis
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Shenzhen Xinzhengyu Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
Record
| Listed by | Waldemar Link GmbH & Co. KG, Germany |
|---|---|
| FDA product code | GAH |
| Device type | Stylet, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-20 |
| Record revised | 2023-05-03 (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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15-2201/35 | In distribution | |
| 99-0700/34 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lion | Hans Biomed Corp. | 17 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 9 |
| Orthopediatrics Instrumentation | Orthopediatrics, Corp | 7 |
| Summa Orthopaedics System Surgical Instrument | Jeil Medical Corporation | 6 |
| Surgical Instrument | Jeil Medical Corporation | 6 |
| OrthoPediatrics Cannulated Screw System | Orthopediatrics, Corp | 6 |
| Osseoflex® | Merit Medical Systems, Inc. | 6 |
| Inlet System Surgical Instrument | Jeil Medical Corporation | 5 |
| Disc Preparation Instruments | Highridge Medical, LLC | 5 |
| Symmetry Frazier | Aspen Surgical Products, Inc. | 5 |
| Visualase | Medtronic Navigation, Inc. | 5 |
| Prometheus System Surgical Instrument | Jeil Medical Corporation | 5 |
Showing 12 of 50. All products under Stylet, Surgical, General & Plastic Surgery
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.