Bit, Surgical
High Performance Stainless Steel Drill Bit
6manufacturers in China registered for this device type
42catalogue 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 | Stryker Sustainability Solutions, United States |
|---|---|
| FDA product code | GFG |
| Device type | Bit, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Reprocessor, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2024-12-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 85 to 230 mm; length 130 to 300 cm |
| Distribution end date | 2024-12-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N/A | Diameter: 3.5 Millimeter | Withdrawn |
| N/A | Diameter: 2.8 Millimeter | Withdrawn |
| N/A | Length 110.0 mm | Withdrawn |
| N/A | Diameter: 4.0 Millimeter | Withdrawn |
| N/A | Diameter: 2.5 Millimeter | Withdrawn |
| N/A | Diameter: 2.0 Millimeter | Withdrawn |
| N/A | Diameter: 4.2 Millimeter | Withdrawn |
| N/A | Diameter: 2.5 Millimeter | Withdrawn |
| N/A | Diameter: 2.0 Millimeter | Withdrawn |
| N/A | Diameter: 2.8 Millimeter | Withdrawn |
| N/A | Diameter: 3.5 Millimeter | Withdrawn |
| N/A | Diameter: 2.0 Millimeter | Withdrawn |
| N/A | Diameter: 2.5 Millimeter | Withdrawn |
| N/A | Diameter: 2.5 Millimeter | Withdrawn |
| N/A | Diameter: 2.9 Millimeter | Withdrawn |
| N/A | Diameter: 4.3 Millimeter | Withdrawn |
| N/A | Length 127.0 mm | Withdrawn |
| N/A | Diameter: 2.0 Millimeter | Withdrawn |
| N/A | Length 230.0 mm | Withdrawn |
| N/A | Length 130.0 cm | Withdrawn |
| N/A | Diameter: 3.5 Millimeter | Withdrawn |
| N/A | Diameter: 2.9 Millimeter | Withdrawn |
| N/A | Length 130.0 mm | Withdrawn |
| N/A | Diameter: 4.0 Millimeter | Withdrawn |
| N/A | Length 110.0 mm | Withdrawn |
| N/A | Diameter: 4.0 Millimeter | Withdrawn |
| N/A | Length 162.0 mm | Withdrawn |
| N/A | Length 110.0 mm | Withdrawn |
| N/A | Diameter: 2.7 Millimeter | Withdrawn |
| N/A | Length 130.0 mm | Withdrawn |
| N/A | Length 100.0 mm | Withdrawn |
| N/A | Diameter: 4.5 Millimeter | Withdrawn |
| N/A | Diameter: 4.2 Millimeter | Withdrawn |
| N/A | Length 125.0 mm | Withdrawn |
| N/A | Length 85.0 mm | Withdrawn |
| N/A | Diameter: 3.5 Millimeter | Withdrawn |
| N/A | Diameter: 2.5 Millimeter | Withdrawn |
| N/A | Length 125.0 mm | Withdrawn |
| N/A | Length 145.0 mm | Withdrawn |
| N/A | Diameter: 1.5 Millimeter | Withdrawn |
| N/A | Length 110.0 mm | Withdrawn |
| N/A | Diameter: 2.8 Millimeter | Withdrawn |
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 |
| 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 |
| Bit, Surgical | Synthes Gmbh | 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.