Helmut Zepf
Trephine SET FOR Augmentation 3D ONE Step Augmentation KIT ACC. DR. Giesenhagen >> NEW Composition
6manufacturers in China registered for this device type
28catalogue 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 | Helmut Zepf Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | HWK |
| Device type | Trephine |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-11-25 |
| Record revised | 2024-04-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 08.911.30 | In distribution | |
| 08.910.13 | In distribution | |
| 08.912.75 | In distribution | |
| 08.910.03 | In distribution | |
| 08.910.10F | In distribution | |
| 08.910.09S | In distribution | |
| 08.912.10 | In distribution | |
| 08.910.11S | In distribution | |
| 08.910.09F | In distribution | |
| 08.910.13F | In distribution | |
| 08.910.02 | In distribution | |
| 08.910.04 | In distribution | |
| 08.910.05 | In distribution | |
| 08.910.13S | In distribution | |
| 08.910.08S | In distribution | |
| 08.910.08 | In distribution | |
| 08.910.11F | In distribution | |
| 08.910.09 | In distribution | |
| 08.910.01 | In distribution | |
| 08.910.10 | In distribution | |
| 08.910.07 | In distribution | |
| 08.910.10S | In distribution | |
| 08.910.08F | In distribution | |
| 47.500.31 | In distribution | |
| 08.910.12 | In distribution | |
| 08.912.50 | In distribution | |
| 08.910.11 | In distribution | |
| 08.910.06 | 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 |
| 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.