Who else makes this device?

Name: Bone Cut Kit
Brand: Bone Cut Kit

Bone Cut Kit

Catalogue number Bone Cut Kit, listed by Nakanishi Inc., Japan, under Drill, Bone, Powered. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangxi (1), Guangdong (1).

Chinese manufacturers registered for FDA product code DZI
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

Regulatory record for Bone Cut Kit
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 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Bone Cut Kit
Catalogue number	Size	Status
Bone Cut Kit		In distribution

Same Product Code

Other products under the same FDA 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
VarioSurg	Nakanishi Inc.	22
Nobel Biocare®	Nobel Biocare AB	20

Showing 12 of 265. All products under Drill, Bone, Powered

510(K) Clearances

FDA 510(k) clearances naming this product code
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.

Recalls naming the identifiers of Bone Cut Kit
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.