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The trephine, with a 6.0mm diameter tri shank attachment, is used to core the cortical bone around the 4.0mm compression screw head in order to initiate the anchoring of the screw head.
6manufacturers in China registered for this device type
2catalogue 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 | Newdeal Sas, United States |
|---|---|
| FDA product code | HWK |
| Device type | Trephine |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2017-05-26 |
| Record revised | 2024-04-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2027-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 119580ND | 6.5mm inner/7.5mm outer diameter X 70mm length | In distribution |
| 119590ND | 10.5mm inner/11.5mm outer diameter X 80mm length | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ACE | Ace Surgical Supply Co., Inc. | 58 |
| Shukla Trephine S9TREPHINE | Shukla Medical | 42 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 40 |
| 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 |
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.