Surgical Direct
7 inch Bone File, double end no. 12A pattern, one end plain, other end cross serrated
2manufacturers in China registered for this device type
531catalogue 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 | Surgical Direct, Inc., United States |
|---|---|
| FDA product code | KDG |
| Device type | Chisel (Osteotome) |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2025-10-14 |
| Record revised | 2025-07-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Distribution end date | 2025-03-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SD62-62202 | In distribution | |
| SD14537-1000 | In distribution | |
| SD92161416 | In distribution | |
| SD91445314 | In distribution | |
| SD92163710 | In distribution | |
| SD92164601 | In distribution | |
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| SD91448225 | In distribution | |
| SD91445819 | In distribution | |
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| SD921637080 | In distribution | |
| SD92163814 | In distribution | |
| SD91445913 | In distribution | |
| SD921368101 | In distribution | |
| SD921637012 | In distribution | |
| SD91440408 | In distribution | |
| SDM41410 | In distribution | |
| SD921611200 | In distribution | |
| SD921638104 | In distribution | |
| SD91440604 | In distribution | |
| SD92136010 | In distribution | |
| SD91448215 | In distribution | |
| SD91448244 | In distribution | |
| SD914653112 | In distribution | |
| SD92139501 | In distribution | |
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| SD914408100 | In distribution | |
| SD921802118 | In distribution | |
| SD14656-1002 | In distribution | |
| SD91448015 | In distribution | |
| SD14537-2006 | In distribution | |
| SD91443721 | In distribution | |
| SD62-62210 | In distribution | |
| SD62-62208 | In distribution | |
| SD921640100 | In distribution | |
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| SDM36530 | In distribution | |
| SD14537-2008 | In distribution | |
| SD14656-1000 | In distribution | |
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Quinelato | Schobell Industrial Ltda | 70 |
| Novo Surgical | Novo Surgical, Inc. | 67 |
| Stille Osteotomes | Stille AB | 65 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 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.