Specials

Med Torque Torque-Limiting Driver, Mondo T-Handle, 85 in-lbs

Registry build 21.09.26
53manufacturers in China registered for this device type
481catalogue 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 Specials
Listed by Seaspine Orthopedics Corporation, United States
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2024-03-06
Record revised 2025-10-24 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Distribution end date 2022-04-19

Catalogue Numbers

Catalogue numbers for Specials
Catalogue number Size Status
SR-1179-08 In distribution
SR-1382-23 In distribution
SR-1013-05 In distribution
SR-0484 In distribution
SR-1252 In distribution
SR-1481 In distribution
SR-0991-16 In distribution
SR-0516-2810-07 In distribution
SR-0642-16 In distribution
SR-0500 In distribution
SR-1411 In distribution
SR-0263 In distribution
SR-0735 In distribution
SR-1140 In distribution
SR-0860 In distribution
SR-1171-20 In distribution
SR-0465 In distribution
SR-0893 In distribution
SR-0940 In distribution
SR-0245-10 In distribution
SR-0655 In distribution
SR-1517 In distribution
SR-1177 In distribution
SR-0187-10 In distribution
SR-1335 In distribution
SR-0948 In distribution
SR-0642-10 In distribution
SR-1495 In distribution
SR-0588 In distribution
SR-0329 In distribution
SR-0324-10 In distribution
SR-1417 In distribution
SR-0245-12 In distribution
SR-0201 In distribution
SR-0516-2810-13 In distribution
SR-1058 In distribution
SR-1112 In distribution
SR-0245-14 In distribution
SR-0339 In distribution
SR-0769 In distribution
SR-1501-09 In distribution
SR-1107 In distribution
SR-0642-12 In distribution
SR-0429-03 In distribution
SR-0453 In distribution
SR-0366-01 In distribution
SR-0667 In distribution
SR-0698-17 In distribution
SR-0651 In distribution
SR-0799 In distribution
SR-0360-05 In distribution
SR-1013-06 In distribution
SR-1404-12-10 In distribution
SR-0616 In distribution
SR-0613 In distribution
SR-0451 In distribution
SR-0360-06 In distribution
SR-0412 In distribution
SR-0642-13 In distribution
SR-0852 In distribution
SR-1492-15 In distribution
SR-0531 In distribution
SR-0605 In distribution
SR-1139-08 In distribution
SR-0252 In distribution
SR-1444 In distribution
SR-1181 In distribution
SR-1013-09 In distribution
SR-1470 In distribution
SR-0679 In distribution
SR-1173-14 In distribution
SR-0668 In distribution
SR-0293 In distribution
SR-0427 In distribution
SR-0516-2810-09 In distribution
SR-0834 In distribution
SR-0446-02 In distribution
SR-0536-03 In distribution
SR-0823 In distribution
SR-0429-02 In distribution
SR-0450 In distribution
SR-0485 In distribution
SR-0831 In distribution
SR-0366-05 In distribution
SR-1010 In distribution
SR-0366-03 In distribution
SR-0846-3 In distribution
SR-0631 In distribution
SR-0557-01 In distribution
SR-0411 In distribution
SR-0429-01 In distribution
SR-1202 In distribution
SR-0516-2815-10 In distribution
SR-0594 In distribution
SR-0380 In distribution
SR-0516-2815-16 In distribution
SR-0517-16 In distribution
SR-0652 In distribution
SR-0810 In distribution
SR-0255 In distribution
SR-0446-03-02 In distribution
SR-0245-08 In distribution
SR-0467 In distribution
SR-1424 In distribution
SR-1211 In distribution
SR-0301 In distribution
SR-1511 In distribution
SR-1179-16 In distribution
SR-0656 In distribution
SR-1053 In distribution
SR-0446-03-01 In distribution
SR-0916 In distribution
SR-0806 In distribution
SR-1203 In distribution
SR-1188 In distribution
SR-0375 In distribution
SR-0276-14 In distribution
SR-0297 In distribution
SR-1409 In distribution
SR-1461 In distribution
SR-0849 In distribution
SR-1117 In distribution
SR-0355 In distribution
SR-1021 In distribution
SR-1426 In distribution
SR-0377-02 In distribution
SR-0802-08 In distribution
SR-0200 In distribution
SR-0347-10 In distribution
SR-0650 In distribution
SR-1041 In distribution
SR-0366-06 In distribution
SR-0974 In distribution
SR-0993 In distribution
SR-1059 In distribution
SR-0515 In distribution
SR-0279 In distribution
SR-1013-11 In distribution
SR-0347-11 In distribution
SR-1308 In distribution
SR-0661-05 In distribution
SR-1179-14 In distribution
SR-1339 In distribution
SR-0395 In distribution
SR-1139-07 In distribution
SR-0337 In distribution
SR-1169 In distribution
SR-0827-02 In distribution
SR-1123 In distribution
SR-1191 In distribution
SR-0621 In distribution
SR-0502 In distribution
SR-0844 In distribution
SR-0348 In distribution
SR-0435 In distribution
SR-1339-14 In distribution
SR-0843 In distribution
SR-0698-15 In distribution
SR-1269 In distribution
SR-1339-08 In distribution
SR-0302 In distribution
SR-0755 In distribution
SR-1363 In distribution
SR-1360 In distribution
SR-0466 In distribution
SR-0308 In distribution
SR-0516-2815-11 In distribution
SR-1069 In distribution
SR-0463 In distribution
SR-1180-16 In distribution
SR-0130-01 In distribution
SR-1460 In distribution
SR-0653 In distribution
SR-1524 In distribution
SR-1173-10 In distribution
SR-0697 In distribution
SR-1346-12 In distribution
SR-1219-12 In distribution
SR-0575 In distribution
SR-0732 In distribution
SR-1337 In distribution
SR-0923 In distribution
SR-0428 In distribution
SR-1007 In distribution
SR-0446-03-03 In distribution
SR-0596 In distribution
SR-0274 In distribution
SR-0606 In distribution
SR-0800 In distribution
SR-1381-28 In distribution
SR-1405-01 In distribution
SR-0824 In distribution
SR-0491 In distribution
SR-0630 In distribution
SR-1078 In distribution
SR-0181 In distribution
SR-1437 In distribution
SR-0915 In distribution
SR-1369 In distribution
SR-1179-12 In distribution
SR-1108-08 In distribution
SR-1281 In distribution
SR-0517-12 In distribution
SR-1346-08 In distribution
SR-1113 In distribution
SR-1206 In distribution
SR-0601 In distribution
SR-0439 In distribution
SR-0218 In distribution
SR-0833 In distribution
SR-1226-10 In distribution
SR-0372 In distribution
SR-0490 In distribution
SR-0661-06 In distribution
SR-1179-10 In distribution
SR-1079 In distribution
SR-0996 In distribution
SR-1083 In distribution
SR-1501-07 In distribution
SR-0516-2810-10 In distribution
SR-1043 In distribution
SR-1142 In distribution
SR-1016 In distribution
SR-0230 In distribution
SR-0516-2815-14 In distribution
SR-0261 In distribution
SR-0457 In distribution
SR-0191 In distribution
SR-0397 In distribution
SR-0276-10 In distribution
SR-0887 In distribution
SR-0383 In distribution
SR-0265 In distribution
SR-0949 In distribution
SR-0827-01 In distribution
SR-1393 In distribution
SR-0362 In distribution
SR-1004 In distribution
SR-0748 In distribution
SR-0686 In distribution
SR-1518 In distribution
SR-1013-12 In distribution
SR-1172 In distribution
SR-0516-2815-15 In distribution
SR-1226 In distribution
SR-0942 In distribution
SR-0794 In distribution
SR-0291 In distribution
SR-0516-2810-12 In distribution
SR-1346-06 In distribution

Showing 250 of 300 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