VarioSurg
22 catalogue numbers from E30RD-S, listed by Nakanishi Inc., Japan, under Drill, Bone, Powered. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
22catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangxi (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
Record
| Listed by | Nakanishi Inc., Japan |
|---|---|
| FDA product code | DZI |
| Device type | Drill, Bone, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4120 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K073678 |
| Record published | 2016-09-16 |
| Record revised | 2026-04-17 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2021-08-25 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E30RD-S | In distribution | |
| SG11 | In distribution | |
| SG9 | In distribution | |
| SCL1D | In distribution | |
| SG16B | In distribution | |
| SG7D | In distribution | |
| H-SG8L | In distribution | |
| SG30 | In distribution | |
| SG10 | In distribution | |
| VarioSurg Unit | In distribution | |
| H-SG8R | In distribution | |
| SG14R | In distribution | |
| SG18L | In distribution | |
| E30LD-S | In distribution | |
| SG15A | In distribution | |
| SG19 | In distribution | |
| SG68 | In distribution | |
| SG5 | In distribution | |
| H-SG8 | In distribution | |
| SG8 | In distribution | |
| VarioSurg Unit | Withdrawn | |
| VarioSurg Unit | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drill, Bone, Powered | Synthes Gmbh | 150 |
| Acteon | Satelec | 87 |
| Neoss Implant System | Neoss AB | 74 |
| Mectron | Mectron SPA | 48 |
| OneDrill Surgical Drill | Osseofuse International Inc. | 48 |
| Silfradent srl | Silfradent SRL | 45 |
| MatrixMANDIBLE | Synthes Gmbh | 31 |
| DIRECTguide™ Step Drill | Implant Direct Sybron Manufacturing LLC | 31 |
| DIRECTguide™ Guided Step Drill | Implant Direct Sybron Manufacturing LLC | 30 |
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 28 |
| Nobel Biocare® | Nobel Biocare AB | 20 |
| Drill, Bone, Powered | Synthes (U.S.A.) LP | 19 |
Showing 12 of 265. All products under Drill, Bone, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254163 | 2025-12-23 |
| K073678 | 2008-07-10 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Nakanishi Inc. | 510(k) number | 2016-07-08 | Class II | Error in labeling | Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are | 2574 units | 2018-06-25 |
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.