Spine Instruments

264 catalogue numbers from LC12-0306, listed by Gbs Commonwealth Co., Ltd., South Korea, under Orthopedic Manual Surgical Instrument. 53 manufacturers in China are registered for this product code.

Registry build 21.09.26
53manufacturers in China registered for this device type
264catalogue 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 Spine Instruments
Listed by Gbs Commonwealth Co., Ltd., South Korea
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Premarket notification Exempt
Record published 2023-11-30

Specifications

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

Catalogue Numbers

Catalogue numbers for Spine Instruments
Catalogue number Size Status
LC12-0306 In distribution
LB02-0302 In distribution
LA05-0101 In distribution
LC17-0102 In distribution
LB01-0350 In distribution
CA03-0201 In distribution
CA02-0219 In distribution
LB01-0613 In distribution
LA01-0304 In distribution
LB01-1165 In distribution
CB05-0101 In distribution
LC12-0302 In distribution
LG16-0101 In distribution
LA01-0105 In distribution
LB01-1701 In distribution
LA14-0104 In distribution
LC12-0301 In distribution
CB06-0102 In distribution
LC14-0058 In distribution
LA02-0111 In distribution
LC16-0102 In distribution
LA02-0101 In distribution
LC15-0201 In distribution
CB37-1709 In distribution
LB07-0101 In distribution
LB01-0601 In distribution
LA14-0103 In distribution
LC11-0404 In distribution
LB02-0111 In distribution
LB05-0101 In distribution
CB37-1708 In distribution
LA07-0101 In distribution
LB01-0955 In distribution
LA15-0103 In distribution
LC12-030C In distribution
LA01-0102 In distribution
LA01-0401 In distribution
LB01-1502 In distribution
LA01-0104 In distribution
LA16-0144 In distribution
LA12-0302 In distribution
LA09-0101 In distribution
LB01-0402 In distribution
LA15-0203 In distribution
LA16-0110 In distribution
LB02-0312 In distribution
LA08-0101 In distribution
LA01-0100 In distribution
LA11-0102 In distribution
LA01-0106 In distribution
LC14-0059 In distribution
CA03-0100 In distribution
LB02-0115 In distribution
LC34-0065 In distribution
LC33-0112 In distribution
LA06-0102 In distribution
CB37-1405 In distribution
LC13-0114 In distribution
LC37-0101 In distribution
LA12-0303 In distribution
LA11-0103 In distribution
LA15-0106 In distribution
LC13-0112 In distribution
CB37-1410 In distribution
CA02-0710 In distribution
LC13-0211 In distribution
LC11-0403 In distribution
LC34-0069 In distribution
LA06-0101 In distribution
LA12-0301 In distribution
LB02-0114 In distribution
LA10-0101 In distribution
LC12-0303 In distribution
LC11-0402 In distribution
LA12-0102 In distribution
LC15-0402 In distribution
LC37-0201 In distribution
LC34-0068 In distribution
LB02-0401 In distribution
CB37-1406 In distribution
LA02-0102 In distribution
LA01-0755 In distribution
LC37-0201 In distribution
LC12-0300 In distribution
LC18-0101 In distribution
LA14-0101 In distribution
LC18-0102 In distribution
LA12-0111 In distribution
LB01-3350 In distribution
LB04-0101 In distribution
LC13-0116 In distribution
LB02-0311 In distribution
LA01-0975 In distribution
CA02-0217 In distribution
LG16-0301 In distribution
LC12-030B In distribution
LB01-0403 In distribution
LB02-0300 In distribution
LA02-0104 In distribution
LC16-0101 In distribution
LA02-0301 In distribution
LC16-0121 In distribution
CA03-0402 In distribution
LB01-0701 In distribution
LC12-0307 In distribution
LA01-0107 In distribution
LA02-0203 In distribution
CA03-0403 In distribution
CB02-0205 In distribution
LB01-0401 In distribution
CA05-0001 In distribution
LC14-0055 In distribution
LB02-0113 In distribution
CB01-0103 In distribution
CB37-1707 In distribution
LB03-0101 In distribution
LA08-0401 In distribution
LA15-0107 In distribution
LC16-0104 In distribution
LA10-0103 In distribution
LA12-0101 In distribution
LA02-0202 In distribution
LB07-0302 In distribution
LC13-0144 In distribution
LA16-0140 In distribution
LC12-030A In distribution
CA02-0802 In distribution
LB06-0101 In distribution
CB05-0201 In distribution
LA09-0201 In distribution
CA02-0221 In distribution
LB01-0412 In distribution
LA01-0545 In distribution
LG15-0226 In distribution
LC13-0143 In distribution
LA01-0403 In distribution
LA01-0575 In distribution
CA05-0101 In distribution
LC16-0100 In distribution
LA01-0765 In distribution
CB01-0101 In distribution
LA06-0100 In distribution
CB37-1706 In distribution
LA01-0404 In distribution
CA02-0602 In distribution
LC14-1000 In distribution
LA01-0955 In distribution
LA16-0160 In distribution
LC34-0066 In distribution
LC13-0142 In distribution
LB02-0411 In distribution
LA01-0103 In distribution
CB37-1407 In distribution
LC34-0067 In distribution
LB01-1601 In distribution
CA03-0101 In distribution
LC13-0141 In distribution
CA02-0225 In distribution
LA16-0150 In distribution
LB04-0201 In distribution
LC34-0064 In distribution
LB01-0965 In distribution
LA02-0204 In distribution
LC34-0062 In distribution
LA01-0555 In distribution
LC15-0301 In distribution
LC15-0302 In distribution
LB01-0602 In distribution
LA07-0201 In distribution
LA15-0109 In distribution
LA12-0104 In distribution
LA01-0945 In distribution
LA01-0201 In distribution
LC33-0111 In distribution
LA01-0302 In distribution
LC13-0113 In distribution
LB01-0151 In distribution
LA09-0502 In distribution
CA02-0501 In distribution
LA02-0201 In distribution
CB37-1408 In distribution
LA09-0401 In distribution
LC11-0401 In distribution
LC16-0103 In distribution
LC14-0053 In distribution
LA01-0565 In distribution
LB01-2350 In distribution
LA01-0745 In distribution
LA12-0202 In distribution
LA11-0101 In distribution
LA13-0101 In distribution
LC13-0117 In distribution
LA16-0142 In distribution
CB37-1705 In distribution
LA01-0402 In distribution
LC14-0052 In distribution
LA01-0203 In distribution
LA08-0403 In distribution
LC15-0101 In distribution
LA08-0301 In distribution
LA16-0130 In distribution
LC13-0115 In distribution
LC34-0061 In distribution
LB07-0301 In distribution
LC12-0305 In distribution
LA12-0106 In distribution
LA12-0105 In distribution
CA02-0714 In distribution
LA15-0104 In distribution
LC34-0063 In distribution
LB01-1155 In distribution
LB02-0301 In distribution
LA15-0101 In distribution
CA02-0601 In distribution
CB37-1710 In distribution
LB01-0950 In distribution
LA16-0120 In distribution
LB01-1055 In distribution
LB01-0603 In distribution
LB02-0303 In distribution
LA01-0303 In distribution
LB01-0152 In distribution
LG16-0302 In distribution
LA01-0535 In distribution
LA02-0112 In distribution
CB37-1409 In distribution
CB01-0102 In distribution
CA02-0223 In distribution
LA01-0965 In distribution
LC37-0102 In distribution
LB06-0201 In distribution
LA02-0302 In distribution
LC12-0308 In distribution
LA01-0301 In distribution
LA09-0501 In distribution
LC15-0501 In distribution
LB05-0102 In distribution
LC14-0050 In distribution
LC13-0111 In distribution
LC14-0051 In distribution
LA08-0201 In distribution
LC14-0056 In distribution
LA02-0503 In distribution
LB01-0801 In distribution
LA12-0103 In distribution
CA04-0101 In distribution
LA09-0402 In distribution
LC12-0304 In distribution
LC34-0060 In distribution
LA14-0102 In distribution

Showing 250 of 264 catalogue numbers.

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