Pass LP
Spatula OF Lenke ILK
4manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Jiangsu (1).
| 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 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
Record
| Listed by | Medicrea International, France |
|---|---|
| FDA product code | HXR |
| Device type | Spatula, Orthopedic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-01-26 |
| Record revised | 2023-03-16 (version 7) |
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 |
| Distribution end date | 2023-01-10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MS241 | Withdrawn | |
| MS242 | Withdrawn | |
| A02110030 | Withdrawn | |
| A01110060 | Withdrawn | |
| A01110050 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| gSource | Gsource, LLC. | 27 |
| Kohdent | Kohler Medizintechnik GmbH | 10 |
| Hunter | Wright Medical Technology, Inc. | 9 |
| Custom | Medicrea International | 7 |
| Rema Shaver Blades | Dewimed Medizintechnik Gmbh | 7 |
| P.l.u.s.® | Spinevision SAS | 5 |
| Hayden Medical | Hayden Medical Inc | 3 |
| Inka | The Trustee for Kaiser Family Trust | 2 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 2 |
| Gill | The Radebaugh-Fetzer Company | 1 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 1 |
| Spatula, Orthopedic | Spinevision SAS | 1 |
Showing 12 of 19. All products under Spatula, Orthopedic
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.