Medtronic Reusable Instruments
Chisel EX0318024 4MM Angl BX - 40DEG RGT
2manufacturers in China registered for this device type
65catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (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 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | KDG |
| Device type | Chisel (Osteotome) |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Premarket notification | Exempt |
| Record published | 2022-10-07 |
| Record revised | 2023-07-13 (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 |
| Distribution end date | 2026-04-27 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X0918017 | In distribution | |
| 9094224 | In distribution | |
| 9074012 | In distribution | |
| 9094212 | In distribution | |
| EX0222024 | In distribution | |
| X1105105 | In distribution | |
| 9074008 | In distribution | |
| 907-912 | In distribution | |
| X0518051 | In distribution | |
| 9095212 | In distribution | |
| 9094222 | In distribution | |
| 807-923 | In distribution | |
| EX0318024 | In distribution | |
| 9094102 | In distribution | |
| X0518050 | In distribution | |
| 9095211 | In distribution | |
| 9094223 | In distribution | |
| 9094104 | In distribution | |
| EX1112005 | In distribution | |
| X0518053 | In distribution | |
| 9198408 | In distribution | |
| EX0112119 | In distribution | |
| 9074010 | In distribution | |
| EX0318026 | In distribution | |
| 9095221 | In distribution | |
| EX1118049 | In distribution | |
| EX0318028 | In distribution | |
| 9094215 | In distribution | |
| 9094214 | In distribution | |
| EX1112004 | In distribution | |
| 9094213 | In distribution | |
| EX0318030 | In distribution | |
| 9094105 | In distribution | |
| 9198410 | In distribution | |
| EX1118050 | In distribution | |
| 9094225 | In distribution | |
| 9094211 | In distribution | |
| 9074014 | In distribution | |
| 9095102 | In distribution | |
| 9094221 | In distribution | |
| 9095222 | In distribution | |
| EX0318029 | In distribution | |
| EX0418003 | In distribution | |
| 9198412 | In distribution | |
| X1204128 | In distribution | |
| 9198414 | In distribution | |
| EX0418002 | In distribution | |
| 9095101 | In distribution | |
| EX0318023 | In distribution | |
| EX0418001 | In distribution | |
| 9094101 | In distribution | |
| EX1118048 | In distribution | |
| X1204129 | In distribution | |
| EX0318027 | In distribution | |
| X1004819 | In distribution | |
| EX0318025 | In distribution | |
| 9094103 | In distribution | |
| EX1118047 | In distribution | |
| Y0599-043 | Withdrawn | |
| Y0899-013 | Withdrawn | |
| X0503019 | Withdrawn | |
| Y0999-053 | Withdrawn | |
| Y0599-044 | Withdrawn | |
| Y0999-051 | Withdrawn | |
| Y0999-052 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 531 |
| Quinelato | Schobell Industrial Ltda | 70 |
| Novo Surgical | Novo Surgical, Inc. | 67 |
| Stille Osteotomes | Stille AB | 65 |
| Orthomed | Ortho-MED, Inc. | 58 |
| Life Instruments | Life Instrument Corp. | 57 |
| Princeton | Princeton Medical Group, Inc. | 46 |
| Osteotome | Koros U.S.A., Inc. | 41 |
| Elmed | Elmed, Inc. | 41 |
| Anmuth Medical International | Anmuth Medical International LLC | 32 |
| Aesculap | Aesculap AG | 31 |
| Chisel | Koros U.S.A., Inc. | 27 |
Showing 12 of 55. All products under Chisel (Osteotome)
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.