In2Bones
Pack 5 Wedge Burrs LG12.75 MM Sterile DIA 3.9 X Length 75 MM
7manufacturers in China registered for this device type
16catalogue 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 | In2Bones SAS, France |
|---|---|
| FDA product code | GFF |
| Device type | Bur, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-06-10 |
| Record revised | 2026-04-27 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: KEEP DRY |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G01 00952 | In distribution | |
| G01 01452 | In distribution | |
| G01 00972 | In distribution | |
| G01 01511 | In distribution | |
| G01 01451 | In distribution | |
| G01 00982 | In distribution | |
| G01 00981 | In distribution | |
| G01 00971 | In distribution | |
| G01 01512 | In distribution | |
| G01 00942 | In distribution | |
| G01 00962 | In distribution | |
| G01 00991 | In distribution | |
| G01 00941 | In distribution | |
| G01 00951 | In distribution | |
| G01 00992 | In distribution | |
| G01 00961 | In distribution |
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 |
|---|---|---|---|---|---|
| 2021-02-09 | Class II | Device Design | This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon burrs diameter 2.0mm length 20mm, possibly causing the breakage of the burr during use. | 60 units | 2024-07-11 |
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.