Novo Surgical

zenith mini-lambotte osteotome, "swiss pattern", 5-1/8" (13.0 cm), straight, set of 9, 4.0 mm, 6.0 mm, 8.0 mm, 10.0 mm, 12.0 mm, 15.0 mm, 18.0 mm, 19.0 mm, 20.0 mm

Registry build 21.09.26
9manufacturers in China registered for this device type
213catalogue 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 Novo Surgical
Listed by Novo Surgical, Inc., United States
FDA product code HWM
Device type Osteotome
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2023-12-18

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 Novo Surgical
Catalogue number Size Status
E93873-31 In distribution
E97842-65 In distribution
N93868-23C In distribution
N93932-29 In distribution
E7914-61 In distribution
N3868-20 In distribution
E3873-15 In distribution
E97914-65 In distribution
E97448-27 In distribution
E97842-61 In distribution
N3866-11 In distribution
N93981-35 In distribution
N6849-14 In distribution
E97842-25 In distribution
N93866-21 In distribution
N93955-26 In distribution
N93950-15 In distribution
N93962-93 In distribution
N93905-00 In distribution
E97841-10 In distribution
E97448-21C In distribution
E97412-11 In distribution
E97914-61 In distribution
E7842-25 In distribution
N93866-33 In distribution
N93981-42 In distribution
N93982-23 In distribution
N93866-23 In distribution
N93950-73 In distribution
N93962-91 In distribution
N93962-83 In distribution
N93905-15 In distribution
N93905-65 In distribution
N93955-29 In distribution
N6849-26 In distribution
N93866-20 In distribution
N6849-27 In distribution
E93873-21 In distribution
N93866-36 In distribution
N6849-28 In distribution
E97411-05 In distribution
E3873-21 In distribution
N93955-31 In distribution
N93981-32 In distribution
N93982-67 In distribution
N93950-23 In distribution
N93962-73 In distribution
N93981-36 In distribution
E93873-26 In distribution
N93868-21 In distribution
N93981-44 In distribution
N93982-73 In distribution
N93981-31 In distribution
E97914-63 In distribution
E97842-13 In distribution
N93868-26 In distribution
E93873-14 In distribution
N93950-21 In distribution
E97412-32 In distribution
N93868-19 In distribution
N93868-15C In distribution
E97842-63 In distribution
N93981-33 In distribution
N93950-27 In distribution
E97842-15 In distribution
E97842-59 In distribution
N93981-37 In distribution
N3955-25 In distribution
N6849-24 In distribution
N93962-23 In distribution
N3905-55 In distribution
N93962-86 In distribution
N93868-15 In distribution
N93955-25 In distribution
E97841-18 In distribution
N93962-43 In distribution
E97412-27 In distribution
E97411-00 In distribution
N3955-26 In distribution
N3932-29 In distribution
E97412-31 In distribution
N93905-21 In distribution
N93868-13 In distribution
E97842-67 In distribution
N3981-44 In distribution
E97842-23 In distribution
N93905-71 In distribution
N93962-21 In distribution
N93950-67 In distribution
N3955-17 In distribution
E97841-23 In distribution
E97841-15 In distribution
N93981-43 In distribution
N93866-16 In distribution
E93873-29 In distribution
E97914-67 In distribution
N93868-13C In distribution
N93905-55 In distribution
E97412-35 In distribution
N3868-13C In distribution
N93981-41 In distribution
N93962-27 In distribution
N3905-61 In distribution
N93950-71 In distribution
N93905-76 In distribution
N93866-35 In distribution
N93982-10 In distribution
E3873-17 In distribution
E97448-23 In distribution
E93873-19 In distribution
N93962-17 In distribution
N93962-01 In distribution
E7914-67 In distribution
E97842-19 In distribution
N3981-34 In distribution
N93868-21C In distribution
N93982-86 In distribution
N93868-29 In distribution
E93873-15 In distribution
N93982-36 In distribution
N93981-38 In distribution
N93950-17 In distribution
N93981-34 In distribution
N93982-41 In distribution
N93955-17 In distribution
E3873-29 In distribution
E97842-17 In distribution
N93866-27 In distribution
E3873-18 In distribution
N93982-31 In distribution
E3873-31 In distribution
N6849-15 In distribution
E97411-08 In distribution
E97411-06 In distribution
E7842-13 In distribution
N93955-33 In distribution
N93981-39 In distribution
N93868-17C In distribution
N93982-81 In distribution
E3873-19 In distribution
E97411-03 In distribution
N93905-61 In distribution
E97411-04 In distribution
N93962-41 In distribution
N93868-23 In distribution
E7842-15 In distribution
N93905-69 In distribution
E97842-21 In distribution
E97448-21 In distribution
N6849-18 In distribution
N93868-01 In distribution
N93868-31 In distribution
N93950-64 In distribution
N93932-23 In distribution
N3981-37 In distribution
N93868-20 In distribution
E3873-13 In distribution
E97411-07 In distribution
N93982-26 In distribution
E97412-29 In distribution
N93982-60 In distribution
N93905-05 In distribution
N93962-67 In distribution
E7842-21 In distribution
N93982-17 In distribution
N93955-19 In distribution
E3873-22 In distribution
E7842-19 In distribution
N93905-17 In distribution
N93905-19 In distribution
N93955-23 In distribution
N3866-20 In distribution
E3873-26 In distribution
N93950-19 In distribution
N93868-17 In distribution
E97412-20 In distribution
N93950-77 In distribution
N93950-14 In distribution
N3932-23 In distribution
N93868-19C In distribution
E97412-12 In distribution
E97412-13 In distribution
N3981-41 In distribution
N3955-29 In distribution
N93982-91 In distribution
N93905-51 In distribution
E97412-26 In distribution
N3955-33 In distribution
N93962-33 In distribution
N93868-25 In distribution
N93962-36 In distribution
N3932-17 In distribution
N93955-36 In distribution
N93932-17 In distribution
E3873-23 In distribution
N93962-51 In distribution
NS02-5295-1 In distribution
N3982-41 In distribution
N93866-19 In distribution
N3955-19 In distribution
E7842-23 In distribution
N93962-71 In distribution
E97448-25 In distribution
E97411-09 In distribution
N93950-69 In distribution
N3905-05 In distribution
N93982-76 In distribution
E93873-23 In distribution
E7914-65 In distribution
N93868-25C In distribution
N93955-21 In distribution
N93950-65 In distribution
N93981-30 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
Boss Instruments Boss Instruments, Ltd. 249
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 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