Ortholoc 3di
14 catalogue numbers from 588S50025, listed by Wright Medical Technology, Inc., United States, under Bit, Surgical. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
14catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Jiangxi Vision Plus Medical Technology Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 6 |
Record
| Listed by | Wright Medical Technology, Inc., United States |
|---|---|
| FDA product code | GFG |
| Device type | Bit, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-17 |
| Record revised | 2022-11-28 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 1.3 to 2.4 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 588S50025 | Size: 2.5mm | In distribution |
| 588S50035 | Size: 3.5mm | In distribution |
| 52031330 | Outer Diameter 1.3 mm | In distribution |
| 52031630 | Outer Diameter 1.6 mm | In distribution |
| 592S50038 | Size: 3.8mm | In distribution |
| 59250030 | Size: 3mm | In distribution |
| 592S50030 | Size: 3mm | In distribution |
| 52032030 | Outer Diameter 2 mm | In distribution |
| 59250038 | Size: 3.8mm | In distribution |
| 52032430 | Outer Diameter 2.4 mm | In distribution |
| 588S50028 | Size: 2.8mm | In distribution |
| 588S50040 | Size: 4mm | In distribution |
| 588S50030 | Size: 3mm | In distribution |
| 588S80020 | Size: 2mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 391 |
| IntelliSense Drill Technology | Mcginley Orthopaedic Innovations, Inc | 60 |
| Conmed | ConMed Corporation | 50 |
| Orthopediatrics Instrumentation | Orthopediatrics, Corp | 43 |
| Bit, Surgical | Stryker Sustainability Solutions | 42 |
| Medline Renewal | Medline Industries, Inc. | 32 |
| Infinity | ConMed Corporation | 26 |
| Pack Precision Allograft Cartilage Kit | Pioneer Surgical Technology, Inc. | 24 |
| Pack™ | Pioneer Surgical Technology, Inc. | 24 |
| Precision Allograft Cartilage Kit (Pack™) | Rti Surgical, Inc. | 24 |
| Made-To-Order | Tornier Inc. | 23 |
| OrthoPediatrics Cannulated Screw System | Orthopediatrics, Corp | 23 |
Showing 12 of 121. All products under Bit, Surgical
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.