Bit, Surgical
3.8MM Three-Fluted Drill BIT QC/CALIBRATED/270MM-STERILE
6manufacturers in China registered for this device type
23catalogue numbers in this listing
1recall
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 | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | GFG |
| Device type | Bit, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-12-31 |
| Record revised | 2024-09-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03.211.455 | In distribution | |
| SD310.972 | In distribution | |
| 03.019.018S | In distribution | |
| SD310.440 | In distribution | |
| SD357.395 | In distribution | |
| SD310.210 | In distribution | |
| 03.820.159S | In distribution | |
| 03.211.432 | In distribution | |
| 310.534 | In distribution | |
| 03.019.016 | In distribution | |
| SD310.143 | In distribution | |
| 03.010.439S | In distribution | |
| SD310.147 | In distribution | |
| 03.168.011 | In distribution | |
| 03.019.016S | In distribution | |
| SD310.148 | In distribution | |
| 03.010.439 | In distribution | |
| SD310.230 | In distribution | |
| 03.019.018 | In distribution | |
| SD357.394 | In distribution | |
| SD357.601 | In distribution | |
| SD357.603 | In distribution | |
| SD310.144 | 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
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-04-29 | Class II | Process control | Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use. | 6690 | 2016-05-19 |
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.