SilCut

SILCUT® PRO Oval Downbiter

Registry build 21.09.26
53manufacturers in China registered for this device type
56catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LXH
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Suzhou Jinsheng Plastic Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17

Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument

Record

Regulatory record for SilCut
Listed by Karl Storz GmbH & Co. KG
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Premarket notification Exempt
Record published 2018-09-04
Record revised 2024-08-01 (version 3)

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 SilCut
Catalogue number Size Status
28171BCN In distribution
28171FC In distribution
28572AD In distribution
28171BDN In distribution
28171BC In distribution
28571OC In distribution
28571BB In distribution
28171KP In distribution
28571AB In distribution
28171SBN In distribution
28171DCN In distribution
28571AC In distribution
28571OA In distribution
28171CC In distribution
28171EC In distribution
28171ACN In distribution
28171DBN In distribution
28171DC In distribution
28572AE In distribution
28572ADL In distribution
28171SLN In distribution
28171FCN In distribution
28171AD In distribution
28171KUN In distribution
28171FB In distribution
28171AB In distribution
28171GC In distribution
28171GBN In distribution
28171ABN In distribution
28171EBN In distribution
28171CCN In distribution
28573BA In distribution
28571ODC In distribution
28571OAC In distribution
28572ADR In distribution
28171KU In distribution
28171SB In distribution
28171GB In distribution
28171KPN In distribution
28571BBR In distribution
28171OAN In distribution
28171OU In distribution
28571BC In distribution
28572O In distribution
28171FBN In distribution
28171AC In distribution
28171ADN In distribution
28171SRN In distribution
28171BBN In distribution
28571O In distribution
28171GCN In distribution
28171CBN In distribution
28171ECN In distribution
28571BBL In distribution
28171OUN In distribution
28171SPN In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Razek Equipamentos Razek Equipamentos Ltda 11,578
Orthopedic Manual Surgical Instrument Globus Medical, Inc. 4,784
Instrument Howmedica Osteonics Corp 4,539
Orthopedic Manual Surgical Instrument Ortho Development Corp. 4,076
Knee Instruments Medacta International SA 3,944
Kyocera Medical Technologies, Inc. Kyocera Medical Technologies, Inc. 3,420
Arthrex® Arthrex, Inc. 3,106
Spine Instruments Medacta International SA 2,892
Orthopedic Manual Surgical Instrument Medtronic Sofamor Danek, Inc. 2,766
Hip Instruments Medacta International SA 1,904
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 1,756
ReLine Nuvasive, Inc. 1,208

Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument

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