Lancer™/Thunderbolt™ Pedicle Screw System

THUNDERBOLT,KWIRE,NITOL,BLUNT-TROCAR,22"

Registry build 21.09.26
53manufacturers in China registered for this device type
208catalogue 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 Lancer™/Thunderbolt™ Pedicle Screw System
Listed by Choice Spine, LP
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
510(k) K132049
Record published 2017-01-21
Record revised 2026-01-15 (version 5)

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
Sizes Length 200 mm; outer diameter 5.5 mm
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Lancer™/Thunderbolt™ Pedicle Screw System
Catalogue number Size Status
SPCL-M001 In distribution
M070-0012 In distribution
M070-0080 In distribution
M070-0106 In distribution
M070-KS122 In distribution
M070-LS124 In distribution
SPCL-M002 In distribution
M070-KTN320 In distribution
M070-0139 In distribution
M070-0055 In distribution
M070-0083 In distribution
M070-0015 In distribution
M070-KN222 In distribution
M070-LS120 In distribution
M070-0075 In distribution
M070-KTN312 In distribution
M070-0014-A1 In distribution
M070-KS324 In distribution
M070-0105 In distribution
M070-0074 In distribution
M070-0014-A2 In distribution
M070-0136 In distribution
M070-KS322 In distribution
M070-0035 In distribution
M070-0042 In distribution
M070-KTN112 In distribution
M070-0138 In distribution
M070-0067 In distribution
M070-0051 In distribution
M070-KN112 In distribution
M070-0089 In distribution
M070-KTS322 In distribution
M070-FD35 In distribution
M070-0056 In distribution
M070-0149-TB In distribution
M070-KS312 In distribution
M070-KTS318 In distribution
M070-KS112 In distribution
M070-KN220 In distribution
M070-KTS220 In distribution
M070-KTN220 In distribution
M070-0026 In distribution
M070-0038 In distribution
M070-KS224 In distribution
M070-LN324 In distribution
M070-0054 In distribution
M070-0076 In distribution
SPCL-MD001 In distribution
M070-0039 In distribution
M070-NVLS In distribution
M070-KTN324 In distribution
M070-KN212 In distribution
SPCL-M004 In distribution
M070-0061 In distribution
M070-0053 In distribution
M070-KS120 In distribution
M070-0025 In distribution
M070-0043 In distribution
M070-KS220 In distribution
M070-KTS122 In distribution
M070-0023 In distribution
M070-LN124 In distribution
SPCL-M008 In distribution
M070-FV01 In distribution
M070-KTN212 In distribution
M070-0092 In distribution
M070-0098 In distribution
M070-KTN118 In distribution
M070-KTS312 In distribution
SPCL-M012 In distribution
M070-KS124 In distribution
M070-KTS324 In distribution
M070-0046 In distribution
M070-0115A In distribution
M070-0003 In distribution
M070-0019 In distribution
SPCL-M013 In distribution
M070-0078 In distribution
M070-0121 In distribution
M070-FV02 In distribution
M070-KS320 In distribution
M070-LS312 In distribution
M070-0052 In distribution
SPCL-M016 In distribution
M070-0110 In distribution
M070-0004 In distribution
M070-0149-XT In distribution
M070-0017 In distribution
M070-KTS222 In distribution
M070-0066 In distribution
M070-LS224 In distribution
M070-0137 In distribution
M070-LN212 In distribution
M070-0085 In distribution
M070-0093 In distribution
M070-LN112 In distribution
M070-0120 In distribution
M070-0020 In distribution
M070-KN120 In distribution
M070-0087 In distribution
M070-0044 In distribution
M070-0088 In distribution
SPCL-M015 In distribution
M070-FD45 In distribution
M070-0064 In distribution
M070-0016 In distribution
M070-LS324 In distribution
M070-0062 In distribution
M070-KN312 In distribution
M070-LS222 In distribution
SPCL-M20056 In distribution
M070-0036 In distribution
M070-KTS212 In distribution
M070-KN320 In distribution
M070-0058 In distribution
M070-0048 In distribution
SPCL-M24056 In distribution
M070-KS212 In distribution
M070-0108 In distribution
SPCL-M009 In distribution
M070-0107 In distribution
SPCL-M003 In distribution
M070-KTS224 In distribution
M070-KTN124 In distribution
SPCL-M005 In distribution
M070-KTN322 In distribution
M070-0057 In distribution
M070-0029 In distribution
M070-FD25 In distribution
M070-LN122 In distribution
M070-LS112 In distribution
M070-0011 In distribution
SPCL-M011 In distribution
SPCL-M010 In distribution
M070-KTS124 In distribution
M070-0028 In distribution
M070-0095 Length 200 mm In distribution
M070-0135 In distribution
M070-KS222 In distribution
M070-KTS118 In distribution
M070-0119 In distribution
M070-0063 In distribution
M070-0059 In distribution
M070-KTS320 In distribution
M070-KTS112 In distribution
M070-KN324 In distribution
M070-0114 In distribution
SPCL-M007 In distribution
M070-0024 In distribution
M070-KTN218 In distribution
M070-0047R In distribution
M070-0096 In distribution
M070-KTN120 In distribution
M070-0045 In distribution
M070-KN224 In distribution
M070-KTN224 In distribution
M070-LN120 In distribution
M070-LS320 In distribution
M070-KTS120 In distribution
M070-0079 In distribution
M070-LN220 In distribution
M070-KN124 In distribution
M070-0002 In distribution
M070-KTN318 In distribution
M070-LS212 In distribution
M070-0082 In distribution
M070-LS220 In distribution
M070-0060 In distribution
M070-LN320 In distribution
M070-LN312 In distribution
M070-0013 In distribution
M070-0148 In distribution
M070-0085 In distribution
M070-NVLC In distribution
M070-0094 In distribution
M070-0018 In distribution
M070-0111 In distribution
M070-0081 In distribution
M070-LN222 In distribution
M070-0011-05 In distribution
M070-KN122 In distribution
SPCL-M014 In distribution
M070-LN224 In distribution
M070-0014-A3 In distribution
M070-0147 In distribution
M070-LS122 In distribution
M070-0100 In distribution
M070-KTN222 In distribution
M070-KTN122 In distribution
M070-0027 In distribution
M070-0065 In distribution
M070-0084 In distribution
M070-LN322 In distribution
SPCL-M006 In distribution
M070-0077 In distribution
M070-0113 In distribution
M070-0037 In distribution
M070-0149-XTM In distribution
M070-0005 In distribution
M070-0047L In distribution
M070-0112 In distribution
M070-0040 In distribution
M070-LS322 In distribution
M070-KTS218 In distribution
M070-0041 In distribution
M070-0086 In distribution
M070-0109 In distribution
M070-KN322 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