Stille Osteotomes
HAND OSTEOTOME STILLE 12 mm curved blade R45 mm phenolic handle 16 cm 6.25 in
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 | Stille AB, Sweden |
|---|---|
| FDA product code | KDG |
| Device type | Chisel (Osteotome) |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 12.5 to 23 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 111-21501-2 | Length 20 cm | In distribution |
| 111-21306-2 | Length 16.5 cm | In distribution |
| 111-21456-10 | Length 16 cm | In distribution |
| 111-21501-1 | Length 20 cm | In distribution |
| 111-21330-12 | Length 21 cm | In distribution |
| 111-21450-6 | Length 12.5 cm | In distribution |
| 111-21305-8 | Length 21 cm | In distribution |
| 111-21330-25 | Length 21 cm | In distribution |
| 111-21310-6 | Length 16.5 cm | In distribution |
| 111-21456-6 | Length 16 cm | In distribution |
| 111-21477-6 | Length 18 cm | In distribution |
| 111-21517-14 | Length 18 cm | In distribution |
| 111-21442-20 | Length 23 cm | In distribution |
| 111-21501-3 | Length 20 cm | In distribution |
| 111-21330-20 | Length 21 cm | In distribution |
| 111-21441-25 | Length 23 cm | In distribution |
| 111-21460-10 | Length 21 cm | In distribution |
| 111-21517-10 | Length 18 cm | In distribution |
| 111-21330-10 | Length 21 cm | In distribution |
| 111-21460-15 | Length 21 cm | In distribution |
| 111-21450-3 | Length 12.5 cm | In distribution |
| 111-21305-6 | Length 21 cm | In distribution |
| 111-21310-8 | Length 16.5 cm | In distribution |
| 111-21456-4 | Length 16 cm | In distribution |
| 111-21477-8 | Length 18 cm | In distribution |
| 111-21456-12 | Length 16 cm | In distribution |
| 111-21441-7 | Length 23 cm | In distribution |
| 111-21477-12 | Length 18 cm | In distribution |
| 111-21450-4 | Length 12.5 cm | In distribution |
| 111-21517-12 | Length 18 cm | In distribution |
| 111-21306-10 | Length 16.5 cm | In distribution |
| 111-21306-8 | Length 16.5 cm | In distribution |
| 111-21442-25 | Length 23 cm | In distribution |
| 111-21441-40 | Length 23 cm | In distribution |
| 111-21330-30 | Length 21 cm | In distribution |
| 111-21306-4 | Length 16.5 cm | In distribution |
| 111-21441-15 | Length 23 cm | In distribution |
| 111-21477-4 | Length 18 cm | In distribution |
| 111-21330-15 | Length 21 cm | In distribution |
| 111-21310-10 | Length 16.5 cm | In distribution |
| 111-21450-10 | Length 12.5 cm | In distribution |
| 111-21450-2 | Length 12.5 cm | In distribution |
| 111-21456-2 | Length 16 cm | In distribution |
| 111-21305-4 | Length 21 cm | In distribution |
| 111-21450-12 | Length 12.5 cm | In distribution |
| 100-111-0084 | Length 16 cm | In distribution |
| 111-21450-11 | Length 12.5 cm | In distribution |
| 111-21477-10 | Length 18 cm | In distribution |
| 111-21442-7 | Length 23 cm | In distribution |
| 100-111-0082 | Length 16 cm | In distribution |
| 111-21441-30 | Length 23 cm | In distribution |
| 111-21450-7 | Length 12.5 cm | In distribution |
| 111-21305-10 | Length 21 cm | In distribution |
| 111-21441-20 | Length 23 cm | In distribution |
| 111-21450-9 | Length 12.5 cm | In distribution |
| 111-21450-8 | Length 12.5 cm | In distribution |
| 111-21310-15 | Length 16.5 cm | In distribution |
| 111-21460-20 | Length 21 cm | In distribution |
| 111-21456-8 | Length 16 cm | In distribution |
| 100-111-0083 | Length 16 cm | In distribution |
| 111-21305-12 | Length 21 cm | In distribution |
| 111-21306-6 | Length 16.5 cm | In distribution |
| 111-21442-15 | Length 23 cm | In distribution |
| 111-21310-12 | Length 16.5 cm | In distribution |
| 111-21450-5 | Length 12.5 cm | In distribution |
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 |
| 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.