Integra® PyroSphere®
Spherical Burr used to create an opening in the bone.
3manufacturers in China registered for this device type
5catalogue 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 | Ascension Orthopedics, Inc., United States |
|---|---|
| FDA product code | HTT |
| Device type | Burr, Orthopedic |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-09-05 |
| Record revised | 2023-01-25 (version 4) |
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 |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BRH44510 | Size 10 | In distribution |
| BRH44540 | Size 40 | In distribution |
| BRH44550 | Size 50 | In distribution |
| BRH44520 | Size 20 | In distribution |
| BRH44530 | Size 30 | 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.