Intervertebral Body Fusion Device

VS ALIF Cage Plate Install Block 30 x 13

Registry build 21.09.26
53manufacturers in China registered for this device type
54catalogue 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 Intervertebral Body Fusion Device
Listed by Precision Spine, Inc., United States
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Manufacturer
Premarket notification Exempt
Record published 2019-03-28

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Intervertebral Body Fusion Device
Catalogue number Size Status
DI00 In distribution
38-9213 In distribution
38-9216 In distribution
12-9020 In distribution
49-DP-0113 In distribution
49-DP-0116 In distribution
38-9210 In distribution
12-9002-16 In distribution
12-9002-07 In distribution
10-1013 In distribution
10-IB30-13 In distribution
PSSRS In distribution
38-9212 In distribution
38-9215 In distribution
44-9001 In distribution
12-9002-13 In distribution
12-9002-12 In distribution
00-9022 In distribution
38-9209 In distribution
12-9002-08 In distribution
12-9002-06 In distribution
38-9207 In distribution
49-DP-0013 In distribution
12-9002-15 In distribution
12-9002-14 In distribution
ALIFINS In distribution
12-9006 In distribution
49-DP-0112 In distribution
49-DP-0014 In distribution
49-DP-0114 In distribution
49-DP-0110 In distribution
38-9211 In distribution
10-IB30-17 In distribution
12-9002-09 In distribution
49-DP-0115 In distribution
10-1004-2 In distribution
49-DP-0012 In distribution
12-9023 In distribution
49-DP-0010 In distribution
49-DP-0016 In distribution
12-9026 In distribution
10-IB30-15 In distribution
10-IB30-11 In distribution
12-9002-10 In distribution
49-DP-0011 In distribution
12-9012 In distribution
12-9003 In distribution
10-IB30-19 In distribution
49-DP-0111 In distribution
10-1006-2 In distribution
27-9001 In distribution
12-9002-11 In distribution
38-9214 In distribution
38-9208 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