Boss Instruments

Black Handled Osteotome 19mm (3/4") Straight, OL 270mm (10-3/4")

Registry build 21.09.26
9manufacturers in China registered for this device type
249catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (3), Shandong (2), Shanghai (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWM
Manufacturer City Province Registered as Device types
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Beijing Fule Science & Technology Development Co., Ltd. Beijing Beijing Manufacturer 31
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31

Record

Regulatory record for Boss Instruments
Listed by Boss Instruments, Ltd., United States
FDA product code HWM
Device type Osteotome
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2024-02-29

Specifications

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

Catalogue Numbers

Catalogue numbers for Boss Instruments
Catalogue number Size Status
70-3627 In distribution
93-0036A In distribution
70-3670 In distribution
93-0034L In distribution
70-3778 In distribution
70-3631 In distribution
70-3829 In distribution
70-3630 In distribution
70-3699 In distribution
93-0035L In distribution
70-3794-9 In distribution
70-3591 In distribution
70-3640 In distribution
70-3610 In distribution
93-0033 In distribution
70-3783-9 In distribution
70-4064 In distribution
70-3587 In distribution
70-3596 In distribution
93-0082 In distribution
70-3607 In distribution
93-0037 In distribution
70-3799 In distribution
70-3690 In distribution
70-3642 In distribution
70-3609 In distribution
70-3705 In distribution
93-0039L In distribution
70-3800B In distribution
93-0120 In distribution
96-5650 In distribution
93-0160 In distribution
70-3800 In distribution
93-0040L In distribution
70-3700 In distribution
70-3598 In distribution
70-3735 In distribution
70-3820A In distribution
70-3819 In distribution
96-5646 In distribution
96-5626 In distribution
70-3825 In distribution
93-0072 In distribution
70-3595 In distribution
70-3688 In distribution
70-3730 In distribution
96-5640 In distribution
70-3752 In distribution
70-3626 In distribution
93-0170 In distribution
70-3621 In distribution
70-3787 In distribution
93-0038L In distribution
93-0101 In distribution
70-3828 In distribution
70-3614 In distribution
70-3654 In distribution
70-3635 In distribution
70-3623 In distribution
93-0186 In distribution
70-3841 In distribution
70-3656 In distribution
70-3588 In distribution
70-3822 In distribution
70-3583 In distribution
70-3651 In distribution
93-0143 In distribution
70-3653 In distribution
93-0172 In distribution
93-0038 In distribution
70-3684 In distribution
70-3945 In distribution
70-3586 In distribution
70-4057 In distribution
70-3611 In distribution
70-3782-7 In distribution
70-3691 In distribution
70-3736 In distribution
70-3821 In distribution
70-3779 In distribution
93-0146 In distribution
70-3751 In distribution
93-0044L In distribution
70-3843 In distribution
93-0118 In distribution
70-3632 In distribution
70-4055 In distribution
93-0031L In distribution
70-3750 In distribution
93-0140 In distribution
70-3790 In distribution
70-3606 In distribution
70-3784 In distribution
93-0033L In distribution
930-1205 In distribution
70-3792 In distribution
73-1566 In distribution
70-3797 In distribution
93-0162 In distribution
70-3880 In distribution
70-3589 In distribution
93-0176 In distribution
93-0155 In distribution
70-3625 In distribution
70-3622 In distribution
93-0040 In distribution
70-4065 In distribution
96-5624 In distribution
93-0163 In distribution
70-3676 In distribution
93-0164 In distribution
93-0185 In distribution
93-0045 In distribution
96-5630 In distribution
70-3943 In distribution
93-0105 In distribution
70-3731 In distribution
70-3786 In distribution
93-0043L In distribution
70-3785-15 In distribution
70-3805 In distribution
93-0086 In distribution
70-4053 In distribution
96-5620 In distribution
70-3754 In distribution
70-3585 In distribution
70-4056 In distribution
96-5622 In distribution
70-3613 In distribution
70-3608 In distribution
70-3594 In distribution
70-3593 In distribution
93-0150 In distribution
70-3790-2 In distribution
70-3820 In distribution
93-0031 In distribution
93-0144 In distribution
93-0042L In distribution
70-4058 In distribution
70-3756 In distribution
70-3755 In distribution
70-3590 In distribution
70-3941 In distribution
70-3788 In distribution
93-0116 In distribution
70-3795 In distribution
70-3701 In distribution
93-0036C In distribution
70-3704 In distribution
70-3698 In distribution
93-0041L In distribution
70-3794 In distribution
93-0076 In distribution
93-0106 In distribution
70-3823 In distribution
70-3655 In distribution
70-3734 In distribution
70-3686 In distribution
93-0161 In distribution
70-3584 In distribution
70-3673 In distribution
70-3801 In distribution
70-3767 In distribution
93-0036 In distribution
70-3796 In distribution
70-3782 In distribution
93-0115 In distribution
70-3783 In distribution
70-3820B In distribution
70-3692 In distribution
93-0099 In distribution
93-0174 In distribution
70-3793 In distribution
70-3695 In distribution
70-3800A In distribution
96-5642 In distribution
70-3785 In distribution
96-5644 In distribution
70-3694 In distribution
70-3781 In distribution
70-3620 In distribution
70-3753 In distribution
93-0070 In distribution
93-0145 In distribution
93-0035B In distribution
93-0095 In distribution
93-0184 In distribution
70-3842 In distribution
93-0039 In distribution
70-3733 In distribution
70-3810 In distribution
70-3605 In distribution
93-0036L In distribution
70-3650 In distribution
70-3806 In distribution
93-0142 In distribution
93-0074 In distribution
70-3824 In distribution
93-0080 In distribution
93-0141 In distribution
70-3803 In distribution
70-3804 In distribution
93-0190 In distribution
70-4054 In distribution
70-3652 In distribution
93-0117 In distribution
70-3629 In distribution
93-0090 In distribution
70-3789 In distribution
93-0041 In distribution
70-3645 In distribution
93-0042 In distribution
70-3702 In distribution
93-0043 In distribution
70-3671 In distribution
93-0030L In distribution
70-3641 In distribution
93-0119 In distribution
70-3633 In distribution
70-3570 In distribution
70-3840 In distribution
93-0035 In distribution
93-0044 In distribution
70-3628 In distribution
93-0110 In distribution
93-0032 In distribution
70-3732 In distribution
96-5648 In distribution
73-1564 In distribution
70-3675 In distribution
93-0084 In distribution
70-3791 In distribution
70-3674 In distribution
70-3592 In distribution
93-0034 In distribution
93-0030 In distribution
96-5628 In distribution
70-3597 In distribution
70-3672 In distribution
70-3720 In distribution
93-0097 In distribution
70-3780 In distribution
70-3612 In distribution
70-3737 In distribution
93-0032L In distribution
93-0078 In distribution
70-3844 In distribution
70-3624 In distribution
70-3802 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Millennium Avalign Technologies, Inc. 300
Life Instruments Life Instrument Corp. 283
Osteotome KLS-Martin L.P. 262
MSI Precision Specialty Instruments MED Saver, Inc. 243
Innomed, Inc. Innomed, Inc. 241
Ambler Surgical Ambler Surgical, LLC 226
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 225
Novo Surgical Novo Surgical, Inc. 213
Novo Surgical Inc. Novo Surgical, Inc. 177
Osteotome Biomet Microfixation 170
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 158
Zoll-Dental Zoll-Dental 132

Showing 12 of 279. All products under 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer