Arthrex®
BURR,ROUND,HL,RETRACT,8 FLUTE,5.0MMX18CM
7manufacturers in China registered for this device type
86catalogue 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 | Arthrex, Inc., 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, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-09-19 |
| Record revised | 2026-05-29 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 5 |
| Distribution end date | 2025-05-26 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AR-S8507OBE | In distribution | |
| AR-8400HSO | In distribution | |
| AR-S8407RBE | In distribution | |
| AR-8450CTS | In distribution | |
| AR-SOV-R30-280 | In distribution | |
| AR-7300RBE | In distribution | |
| AR-8550COT | In distribution | |
| AR-SSW-35-280 | In distribution | |
| AR-8550COE | In distribution | |
| AR-8150PX-45-1 | In distribution | |
| AR-SOV-R30-330CD | In distribution | |
| AR-8400CSS | In distribution | |
| AR-8500RFOE | In distribution | |
| AR-6500XBE | In distribution | |
| AR-8500FOE | In distribution | |
| AR-8550PR-1 | In distribution | |
| AR-8400OBE | In distribution | |
| AR-SOV-R30-330 | In distribution | |
| AR-8550FOS | In distribution | |
| AR-8500BL | In distribution | |
| AR-SOV-R30-280CD | In distribution | |
| AR-8550CRE | In distribution | |
| AR-6500RRBE | In distribution | |
| AR-S8557OBT | In distribution | |
| AR-8500COS | In distribution | |
| AR-8550HSO | In distribution | |
| AR-SMH-30-330D | In distribution | |
| AR-8550RBE | In distribution | |
| AR-8500FOT | In distribution | |
| AR-6400RRBE | In distribution | |
| AR-300-B301S | In distribution | |
| AR-7400RBE | In distribution | |
| AR-SMH-30-280D | In distribution | |
| AR-8550COS | In distribution | |
| AR-SFW-35-280 | In distribution | |
| AR-8400CRE | In distribution | |
| AR-8550OBT | In distribution | |
| AR-6500RBD | In distribution | |
| AR-8550TBT | In distribution | |
| AR-8500OBE | In distribution | |
| AR-8500CRE | In distribution | |
| AR-7400HSO | In distribution | |
| AR-8450CSS | In distribution | |
| AR-SMH-30-330 | In distribution | |
| AR-9300OBT | In distribution | |
| AR-SMH-30-330CD | In distribution | |
| AR-6400RBE | In distribution | |
| AR-8150PX-45 | In distribution | |
| AR-6500VBE | In distribution | |
| AR-6500RBE | In distribution | |
| AR-8550PR | In distribution | |
| AR-SSW-35-330 | In distribution | |
| AR-9350RBT | In distribution | |
| AR-8500TBT | In distribution | |
| AR-9350OBT | In distribution | |
| AR-8500FOS | In distribution | |
| AR-SFW-35-330 | In distribution | |
| AR-9280NOT-1 | In distribution | |
| AR-SOV-R30-330XD | In distribution | |
| AR-8350PR | In distribution | |
| AR-8500RBE | In distribution | |
| AR-7300OBT | In distribution | |
| AR-6550RRBE | In distribution | |
| AR-8400PR | In distribution | |
| AR-SOV-R50-280XD | In distribution | |
| AR-9280NOT | In distribution | |
| AR-SOV-R50-280 | In distribution | |
| AR-SOV-R50-280CD | In distribution | |
| AR-S8407OBE | In distribution | |
| AR-8350PR-1 | In distribution | |
| AR-8400CTS | In distribution | |
| AR-9350PR | In distribution | |
| AR-7400OBE | In distribution | |
| AR-8550FOT | In distribution | |
| AR-8550RFOE | In distribution | |
| AR-8400RBE | In distribution | |
| AR-SMH-30-280CD | In distribution | |
| AR-8500COT | In distribution | |
| AR-6400RBD | In distribution | |
| AR-SOV-R30-280XD | In distribution | |
| AR-SMH-30-280 | In distribution | |
| AR-8500HSO | In distribution | |
| AR-9300RBT | In distribution | |
| AR-8500COE | In distribution | |
| AR-8550FOE | In distribution | |
| AR-8963TL-01 | 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 |
|---|---|---|---|---|---|
| 2019-01-14 | Class II | Unknown/Undetermined by firm | Devices may generate excessive heat during use. | 2324 | 2023-08-31 |
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.