Osteon
Osteon BUR - Round Diamond, 150-200 Grit, 0.5 X 48 MM
7manufacturers in China registered for this device type
29catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 29 |
| Zonefly Medical Devices Co., Ltd. | Danyang | Jiangsu | Specification developer | 7 |
| Jiangxi Vision Plus Medical Technology Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 6 |
Record
| Listed by | ConMed Corporation, United States |
|---|---|
| FDA product code | GFF |
| Device type | Bur, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-05-24 |
| Record revised | 2024-07-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 30 to 48 mm; outer diameter 0.5 to 6.5 mm |
| Distribution end date | 2024-06-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00505614400 | In distribution | |
| 00505614000 | Length 48 mm | In distribution |
| 00505614200 | Length 48 mm | In distribution |
| 00505611900 | Outer Diameter 4 mm | In distribution |
| 00505611800 | Length 30 mm | In distribution |
| 00505612700 | Outer Diameter 4 mm | In distribution |
| 00505616100 | Outer Diameter 0.5 mm | In distribution |
| 00505614900 | Length 48 mm | In distribution |
| 00505615000 | Length 48 mm | In distribution |
| 00505616800 | Outer Diameter 4 mm | In distribution |
| 00505615900 | Length 48 mm | In distribution |
| 00505616000 | Length 48 mm | In distribution |
| 00505616200 | Outer Diameter 2 mm | In distribution |
| 00505612500 | Length 38 mm | In distribution |
| 00505616700 | Outer Diameter 6 mm | In distribution |
| 00505616500 | Outer Diameter 0.7 mm | In distribution |
| 00505615200 | Outer Diameter 4 mm | In distribution |
| 00505614700 | Length 38 mm | In distribution |
| 00505615800 | Length 48 mm | In distribution |
| 00505616400 | Length 48 mm | In distribution |
| 00505614500 | Length 48 mm | In distribution |
| 00505612800 | Length 38 mm | In distribution |
| 00505614600 | Outer Diameter 3 mm | In distribution |
| 00505611700 | Length 30 mm | In distribution |
| 00505612600 | Length 38 mm | In distribution |
| 00505616300 | Length 48 mm | In distribution |
| 00505614800 | Outer Diameter 4 mm | In distribution |
| 5056-150 | Outer Diameter 5 mm | Withdrawn |
| 00505611600 | Outer Diameter 3 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Komet Surgical Bur | Gebr. Brasseler Gmbh & Co. KG | 1,011 |
| Bur, Surgical, General & Plastic Surgery | Sterilmed, Inc. | 1,001 |
| Medline | Medline Industries, Inc. | 584 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 335 |
| Bur, Surgical, General & Plastic Surgery | Omega Surgical Instruments, Inc. | 312 |
| Bur, Surgical, General & Plastic Surgery | Hager & Meisinger Gesellschaft mit beschränkter Haftung | 170 |
| MicroAire® | Microaire Surgical Instruments LLC | 162 |
| Ultrapower | ConMed Corporation | 155 |
| De Soutter Medical | DE Soutter Medical Ltd. | 143 |
| Jota | Jota AG | 112 |
| Conmed | ConMed Corporation | 109 |
| Bur, Round, round shank | Gebr. Brasseler Gmbh & Co. KG | 104 |
Showing 12 of 167. All products under Bur, Surgical, General & Plastic Surgery
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 |
|---|---|---|---|---|---|
| 2015-12-21 | Class II | Mixed-up of materials/components | Metal shavings released from burs during use are due to contact between the bur and the hood of the PreBent Bur assembly. During the manufacturing process an assembly error occurred which caused inadvertent mixing of two sizes of bearings. | 991 pieces | 2018-05-24 |
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.