Bone Management
Guided Drill System for Implant Site Preparation | developed with Dr. Henriette Lerner
7manufacturers in China registered for this device type
38catalogue numbers in this listing
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 | Hager & Meisinger Gesellschaft mit beschränkter Haftung |
|---|---|
| FDA product code | GFF |
| Device type | Bur, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| 510(k) | K201210 |
| Record published | 2021-09-15 |
| Record revised | 2024-04-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BTEN2 | In distribution | |
| BSK04 | In distribution | |
| ALV18 | In distribution | |
| CTRPL | In distribution | |
| RTR00 | In distribution | |
| BGS00 | In distribution | |
| BBR00 | In distribution | |
| BTEN3 | In distribution | |
| CSPBA | In distribution | |
| BSK03 | In distribution | |
| BMS00 | In distribution | |
| CTR00 | In distribution | |
| BGS01 | In distribution | |
| CTRBA | In distribution | |
| CSL00 | In distribution | |
| CCLBA | In distribution | |
| BMCPR | In distribution | |
| CSP15 | In distribution | |
| CSP12 | In distribution | |
| BSK02 | In distribution | |
| 38171 | In distribution | |
| BMSBA | In distribution | |
| BRSS2 | In distribution | |
| CCR00 | In distribution | |
| CTRI0 | In distribution | |
| BMSPL | In distribution | |
| 3300225205090 | In distribution | |
| BMSTP | In distribution | |
| CTRB2 | In distribution | |
| BMCBA | In distribution | |
| BTEN1 | In distribution | |
| BDS02 | In distribution | |
| 3300225205130 | In distribution | |
| 3300225205110 | In distribution | |
| 38271 | In distribution | |
| BDSMP | In distribution | |
| CSPPL | In distribution | |
| BMC00 | 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
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.