OrthoSolutions ‘System26’ Bone Screws
6.5 & 8.0MM Headless Screw Tray Assembly (EXC. LID)
1manufacturer
38catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | Ortho Solutions Inc, United States |
|---|---|
| FDA product code | OJH |
| Device type | Orthopedic Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Complaint-file establishment |
| 510(k) | K163489 |
| Record published | 2017-03-15 |
| Record revised | 2022-09-16 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OS900004C-NS | In distribution | |
| OS900001B-NS | In distribution | |
| OS900005B-NS | In distribution | |
| OS900001-NS | In distribution | |
| OS900000H-NS | In distribution | |
| OS900005C-NS | In distribution | |
| OS900000C-NS | In distribution | |
| OS900005-NS | In distribution | |
| OS900000I-NS | In distribution | |
| OS900008-NS | In distribution | |
| OS900000D-NS | In distribution | |
| OS900005A-NS | In distribution | |
| OS900004-NS | In distribution | |
| OS900004A-NS | In distribution | |
| OS900002A-NS | In distribution | |
| OS900000G-NS | In distribution | |
| OS900002-NS | In distribution | |
| OS900006C-NS | In distribution | |
| OS900013-NS | In distribution | |
| OS900003A-NS | In distribution | |
| OS900000A-NS | In distribution | |
| OS900006B-NS | In distribution | |
| OS900002B-NS | In distribution | |
| OS900001A-NS | In distribution | |
| OS900006A-NS | In distribution | |
| OS900006-NS | In distribution | |
| OS900000-NS | In distribution | |
| OS900000E-NS | In distribution | |
| OS900000B-NS | In distribution | |
| OS900003C-NS | In distribution | |
| OS900004B-NS | In distribution | |
| OS900001D-NS | In distribution | |
| OS900003B-NS | In distribution | |
| OS900001C-NS | In distribution | |
| OS900002C-NS | In distribution | |
| OS900003-NS | In distribution | |
| OS900007-NS | In distribution | |
| OS900000F-NS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 95,039 |
| Medline Industries, Inc. | Medline Industries, Inc. | 53,097 |
| Avid TruCustom | Avid Medical, Inc. | 3,990 |
| ACS | American Contract Systems, Inc. | 3,812 |
| Halyard | Avid Medical, Inc. | 1,313 |
| Aligned Medical Solutions | Aligned Medical Solutions | 1,272 |
| Regard™ | ROi CPS LLC | 464 |
| Overwatch | Spinal Elements, Inc. | 223 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 191 |
| Lucent L | Spinal Elements, Inc. | 95 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 87 |
| Integra® | Ascension Orthopedics, Inc. | 81 |
Showing 12 of 367. All products under Orthopedic Tray
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.