Remotion
Wrist Instr. PGT Radial Burr, Medium
3manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
Record
| Listed by | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HTT |
| Device type | Burr, Orthopedic |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2025-04-14 (version 7) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 300-1300 | In distribution | |
| 300-1400 | In distribution | |
| 300-1500 | In distribution | |
| 300-1200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Imedicom High Speed Blade | Imedicom Co., Ltd. | 275 |
| Brasseler USA | Provision | 261 |
| Stryker | Provision | 243 |
| MicroAire | Provision | 238 |
| Conmed/Linvatec | Provision | 87 |
| Burr, Orthopedic | Jota AG | 64 |
| gSource | Gsource, LLC. | 54 |
| Brasseler | Provision | 13 |
| Percutaneous Foot Burrs, Arthodesis Burrs | GM DOS Reis Industria E Comercio Ltda | 13 |
| Aesculap | Aesculap AG | 11 |
| Medtronic | Provision | 10 |
| Arthrex | Provision | 8 |
Showing 12 of 117. All products under Burr, Orthopedic
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.