Medtronic Reusable Instruments
Instrument 893-511 T Hndl Trephine 10MM
6manufacturers in China registered for this device type
40catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Shandong (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| 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 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | HWK |
| Device type | Trephine |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2022-10-07 |
| 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 |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X0811126 | In distribution | |
| 6279111 | In distribution | |
| 8367760 | In distribution | |
| X1100017 | In distribution | |
| 6279144 | In distribution | |
| X0196-523R | In distribution | |
| X0196-525L | In distribution | |
| X0196-520R | In distribution | |
| X0196-523L | In distribution | |
| 893-510 | In distribution | |
| EX09103862 | In distribution | |
| 893-511 | In distribution | |
| 893-509 | In distribution | |
| X1195-001 | In distribution | |
| 8367765 | In distribution | |
| 8367745 | In distribution | |
| X0196-525R | In distribution | |
| Y8087750 | In distribution | |
| X0196-522L | In distribution | |
| X0196-522R | In distribution | |
| X0196-521L | In distribution | |
| 5484898 | In distribution | |
| Y8087745 | In distribution | |
| Y8087755 | In distribution | |
| 890-504 | In distribution | |
| Y8087770 | In distribution | |
| X0196-520L | In distribution | |
| Y8087775 | In distribution | |
| 893-530 | In distribution | |
| X0904205 | In distribution | |
| 8367750 | In distribution | |
| X0196-524R | In distribution | |
| X0196-521R | In distribution | |
| X0199-014 | In distribution | |
| X0196-524L | In distribution | |
| Y8087760 | In distribution | |
| X1100018 | In distribution | |
| Y8087780 | In distribution | |
| EX0817013 | In distribution | |
| 6279141 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ACE | Ace Surgical Supply Co., Inc. | 58 |
| Shukla Trephine S9TREPHINE | Shukla Medical | 42 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 28 |
| IdentiTi | Alphatec Spine, Inc. | 22 |
| Zoll-Dental | Zoll-Dental | 20 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 17 |
| Trephine | Synthes Gmbh | 15 |
| Trephine | KLS-Martin L.P. | 14 |
| Moreland | Depuy Orthopaedics, Inc. | 14 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 13 |
| Bradshaw Medical Inc. | Bradshaw Medical Inc. | 13 |
| Fassier-Duval Telescopic IM System | Orthopediatrics Canada ULC | 10 |
Showing 12 of 138. All products under Trephine
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.