COGNiTiON™ Staple System
4 LEG X 20MM Drill Guide
5manufacturers in China registered for this device type
6catalogue 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 | Ortho Solutions Inc, United States |
|---|---|
| FDA product code | HXY |
| Device type | Brace, Drill |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Complaint-file establishment |
| Premarket notification | Exempt |
| Record published | 2024-04-01 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OS380035-NS | In distribution | |
| OS380034-NS | In distribution | |
| OS380031-NS | In distribution | |
| OS380036-NS | In distribution | |
| OS380032-NS | In distribution | |
| OS380033-NS | In distribution |
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 |
| Spider Cervical Plating System | Xtant Medical Holdings, Inc. | 5 |
| Biopsybell | Biopsybell SRL | 5 |
| Acculan II | Aesculap AG | 4 |
| 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.