Burr Coarse 15MM
Catalogue number 19535, listed by Biopro, Inc., United States, under Burr, Orthopedic. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
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 | Biopro, Inc., United States |
|---|---|
| FDA product code | HTT |
| Device type | Burr, Orthopedic |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K061089 |
| Record published | 2019-05-06 |
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, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 19535 | 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.