Mesa® Spinal System

Torque Limiting Handle Size 30 in-lbs (3.4 N-m)

Registry build 21.09.26
53manufacturers in China registered for this device type
200catalogue 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 Mesa® Spinal System
Listed by VB Spine LLC
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Premarket notification Exempt
Record published 2021-05-19
Record revised 2026-04-20 (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 Outer diameter 3.5 to 12.5 mm; length 40 to 169 mm
Distribution end date 2024-07-15

Catalogue Numbers

Catalogue numbers for Mesa® Spinal System
Catalogue number Size Status
PRO-1115 In distribution
PRO-1048-06 Outer Diameter 7 mm In distribution
SP-4182-01 Outer Diameter 3.5 mm In distribution
6201-90056 In distribution
SP-1794-02 Length 40 mm In distribution
6201-90053 In distribution
801-90172 In distribution
6201-90002 In distribution
801-90139 In distribution
PRO-1168-01 In distribution
2601-90017 In distribution
PRO-1048-03 Outer Diameter 5.5 mm In distribution
SP-4182-03 Outer Diameter 4.5 mm In distribution
SP-4233 In distribution
801-90168 In distribution
801-90038 In distribution
SP-2364-07 Outer Diameter 6.5 mm In distribution
801-90134 In distribution
801-90096 In distribution
SP-2364-03 Outer Diameter 4.5 mm In distribution
801-90144 In distribution
SP-4182-04 Outer Diameter 5 mm In distribution
SP-2370 In distribution
SP-4182-09 Outer Diameter 7.5 mm In distribution
6201-90086 In distribution
801-90052 In distribution
801-90207 In distribution
6201-90018 In distribution
801-90166 In distribution
801-90131 In distribution
5601-90006 In distribution
SP-4115-01 Length 145 mm In distribution
6201-90088 In distribution
801-90048 In distribution
801-90137 In distribution
SP-2364-01 Outer Diameter 3.5 mm In distribution
801-90148 In distribution
6201-90071 In distribution
6201-90014 In distribution
801-90200 In distribution
801-90198 In distribution
801-90141 In distribution
801-90066 In distribution
801-90138 In distribution
SP-4099 In distribution
801-90215 In distribution
6201-90087 In distribution
801-90094 In distribution
SP-2474 In distribution
SP-4182-14 Outer Diameter 12.5 mm In distribution
801-90029 In distribution
6201-90080 In distribution
PRO-1209 In distribution
6301-90037 In distribution
6201-90009 In distribution
6201-90033 In distribution
6201-90012 In distribution
801-90173 In distribution
801-90211 In distribution
801-90008 In distribution
801-90147 In distribution
5601-90008 In distribution
SP-1794-01 Length 40 mm In distribution
801-90072 In distribution
SP-2364-02 Outer Diameter 4 mm In distribution
6201-90066 In distribution
SP-4182-02 Outer Diameter 4 mm In distribution
6201-90029 In distribution
801-90067 In distribution
6201-90085 In distribution
6201-90072 In distribution
801-90123 In distribution
SP-2318 In distribution
801-90032 In distribution
801-90049 In distribution
801-90001 In distribution
6201-90054 In distribution
SP-4111 Rod Slot Diameter 6.0 mm In distribution
6201-90011 In distribution
SP-4109 Hexalobe Size 25 In distribution
801-90097 In distribution
801-90074 In distribution
6201-90052 In distribution
801-90122 In distribution
801-90128 In distribution
6201-90069 In distribution
801-90171 In distribution
801-90053 In distribution
SP-4182-12 Outer Diameter 10.5 mm In distribution
801-90183 In distribution
PRO-1251 In distribution
801-90093 In distribution
SP-1720 In distribution
801-90061 In distribution
6201-90079 In distribution
801-90058 In distribution
801-90024 In distribution
801-90208 In distribution
PRO-1048-02 Outer Diameter 5 mm In distribution
PRO-1048-05 Outer Diameter 6.5 mm In distribution
PRO-1048-10 Outer Diameter 10.5 mm In distribution
6201-90084 In distribution
801-90170 In distribution
PRO-1048-11 Outer Diameter 11.5 mm In distribution
801-90177 In distribution
801-90195 In distribution
801-90142 In distribution
801-90091 (M) In distribution
801-90152 In distribution
801-90090 (S) In distribution
PRO-1048-09 Outer Diameter 9.5 mm In distribution
801-90212 In distribution
6201-90034 In distribution
801-90028 In distribution
801-90026 In distribution
801-90092 (L) In distribution
801-90174 In distribution
PRO-1071 In distribution
6201-90027 In distribution
801-90031 In distribution
801-90199 In distribution
801-90140 In distribution
PRO-1233 In distribution
6201-90017 In distribution
PRO-1048-12 Outer Diameter 12.5 mm In distribution
SP-2364-06 Outer Diameter 6 mm In distribution
PRO-1048-08 Outer Diameter 8.5 mm In distribution
6201-90097 In distribution
SP-4182-07 Outer Diameter 6.5 mm In distribution
801-90129 In distribution
6201-90007 In distribution
801-90119 In distribution
801-90164 In distribution
SP-4250 In distribution
PRO-1168-02 In distribution
801-90146 In distribution
SP-4115-02 Length 169 mm In distribution
PRO-1048-07 Outer Diameter 7.5 mm In distribution
801-90070 In distribution
6201-90010 In distribution
801-90121 In distribution
801-90197 In distribution
6201-90013 In distribution
801-90196 In distribution
6201-90070 In distribution
801-90073 In distribution
6201-90050 In distribution
SP-4182-05 Outer Diameter 5.5 mm In distribution
801-90216 In distribution
SP-2004 In distribution
PRO-1048-01 Outer Diameter 4.5 mm In distribution
SP-4182-11 Outer Diameter 9.5 mm In distribution
6201-90049 In distribution
801-90120 In distribution
2601-90016 In distribution
SP-4182-13 Outer Diameter 11.5 mm In distribution
6201-90051 In distribution
801-90143 In distribution
SP-2055 In distribution
801-90025 In distribution
801-90068 In distribution
801-90132 In distribution
801-90206 In distribution
801-90213 In distribution
SP-1580 In distribution
801-90004 In distribution
801-90118 In distribution
801-90059 In distribution
801-90060 In distribution
6201-90095 In distribution
801-90167 In distribution
5601-90007 In distribution
SP-4182-08 Outer Diameter 7 mm In distribution
801-90130 In distribution
801-90027 In distribution
801-90153 In distribution
801-90069 In distribution
801-90054 In distribution
801-90145 In distribution
SP-4182-10 Outer Diameter 8.5 mm In distribution
6201-90001 In distribution
801-90050 In distribution
801-90003 In distribution
801-90051 In distribution
6201-90004 In distribution
6201-90055 In distribution
PRO-1048-04 Outer Diameter 6 mm In distribution
SP-2364-05 Outer Diameter 5.5 mm In distribution
6201-90016 In distribution
801-90180 In distribution
6201-90068 In distribution
SP-2364-04 Outer Diameter 5 mm In distribution
801-90095 In distribution
SP-4259 In distribution
801-90169 In distribution
SP-4182-06 Outer Diameter 6 mm In distribution
801-90214 In distribution
6201-90031 In distribution
SP-2292 Withdrawn
SP-1863 Withdrawn

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