Acculan II
Acculan II Lrg.jacobs Chuck UP TO D7.4MM
5manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Shandong (2).
| 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 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Shandong Banbanni Electronic Technology Co., Ltd. | Linyi | Shandong | Contract manufacturer | 2 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | HXY |
| Device type | Brace, Drill |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-23 |
| Record revised | 2024-12-19 (version 6) |
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, serial number |
| Distribution end date | 2021-08-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GB413R | In distribution | |
| GB439R | Withdrawn | |
| GB412R | Withdrawn | |
| GB416R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 40 |
| Aesculap | Aesculap AG | 14 |
| Volition Plating System | Ortho Solutions Inc | 11 |
| OrthoSolutions ‘System26’ Bone Screws | Ortho Solutions Inc | 7 |
| COGNiTiON™ Staple System | Ortho Solutions Inc | 6 |
| Spider Cervical Plating System | Xtant Medical Holdings, Inc. | 5 |
| Biopsybell | Biopsybell SRL | 5 |
| Plasmafit | Aesculap AG | 4 |
| Cosy | Signus Medizintechnik Gmbh | 4 |
| Aranax Anterior Cervical Plating System | Xtant Medical Holdings, Inc. | 3 |
| 4-Hole Drill Guide | Captiva Spine, Inc. | 3 |
| Kmedic | Teleflex Medical LLC | 3 |
Showing 12 of 48. All products under Brace, Drill
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.