Made-To-Order
Perform Shoulder Depth Stop
6manufacturers in China registered for this device type
23catalogue 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 | Tornier 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, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-11-29 |
| Record revised | 2023-10-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9027440 | Size: 0mm | In distribution |
| 9027384 | Size: XL60 | In distribution |
| 9027831 | In distribution | |
| 9027378 | Size: M40 | In distribution |
| 9027439 | Size: + 0.5mm | In distribution |
| 9027380 | Size: L50 | In distribution |
| 9027448 | Size: 4mm | In distribution |
| 9027450 | Size: 5mm | In distribution |
| 9027376 | Size: M30 | In distribution |
| 9027449 | Size: 4.5mm | In distribution |
| 9027382 | Size: XL40 | In distribution |
| 9027374 | Size: S35 | In distribution |
| 9027442 | Size: 1mm | In distribution |
| 9027445 | Size: 2.5mm | In distribution |
| 9027373 | Size: S30 | In distribution |
| 9027441 | Size: 0.5mm | In distribution |
| 9027443 | Size: 1.5mm | In distribution |
| 9027447 | Size: 3.5mm | In distribution |
| 9027444 | Size: 2mm | In distribution |
| 9027381 | Size: L60 | In distribution |
| 9027383 | Size: XL50 | In distribution |
| 9027446 | Size: 3mm | In distribution |
| 9028135 | 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 |
| 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.