Orthopedic Manual Surgical Instrument

Bone Curette, Angled, 12.0 Serrated Cup, Bayonetted, LH, 45 deg Down

Registry build 21.09.26
53manufacturers in China registered for this device type
4,784catalogue 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 Orthopedic Manual Surgical Instrument
Listed by Globus Medical, Inc., United States
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Manufacturer, Exporter
Premarket notification Exempt
Record published 2021-11-25
Record revised 2024-09-11 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date
Sizes Height 2.3 to 30 mm; width 1 to 50 mm; length 1 to 1000 mm; depth 10 to 29 mm; outer diameter 0.8 to 26 mm; angle -45 to 180 °; lumen/inner diameter 0.8 to 26 mm; length 4 to 8 in
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Orthopedic Manual Surgical Instrument
Catalogue number Size Status
6181.5015 In distribution
643.040 Angle 25 ° In distribution
604.317 Height 17 mm In distribution
6119.1070 In distribution
685.608 Outer Diameter 1.65 mm In distribution
665.227 Depth 11 mm In distribution
655.219 Outer Diameter 9.5 mm In distribution
647.148 Outer Diameter 4.8 mm In distribution
6128.2581 Depth 15 mm In distribution
693.402 Lumen/Inner Diameter 7 mm In distribution
698.128 In distribution
6145.3216 Length 22 mm In distribution
675.613 Height 13 mm In distribution
6145.1814 Lordosis 7 Degree In distribution
682.403 In distribution
624.208 Outer Diameter 8.5 mm In distribution
675.128 In distribution
602.303 In distribution
665.131 Width 12 mm In distribution
626.014 Length 6 mm In distribution
6119.6030 In distribution
6041.0218 Outer Diameter 7.5 mm In distribution
6128.1527 Height 7 mm In distribution
685.614 Outer Diameter 1.45 mm In distribution
685.140 In distribution
6145.4008 Height 8 mm In distribution
6179.7013 In distribution
6206.3008 In distribution
684.418 In distribution
682.400 In distribution
643.082 Width 6.5 mm In distribution
6145.3215 Height 15 mm In distribution
604.310 Height 10 mm In distribution
630.322 In distribution
698.516 Length 70 mm In distribution
6149.6505 In distribution
643.015 In distribution
6147.1210 Lordosis 12 Degree In distribution
676.670 In distribution
602.508 In distribution
675.823 Outer Diameter 23 mm In distribution
6101.0200 In distribution
675.201 Height 12 mm In distribution
668.312 Height 12 mm In distribution
688.170 Length 20 mm In distribution
616.040 In distribution
610.520 Length 20 mm In distribution
646.713 Height 13 mm In distribution
685.295 In distribution
6178.3301 In distribution
615.107 Outer Diameter 3.4 mm In distribution
6136.0429 Height 9 mm In distribution
6145.2008 Lordosis 11 Degree In distribution
676.519 Width 34 mm In distribution
6275.3033 In distribution
622.726 Length 45 mm In distribution
6067.0085 In distribution
655.119 In distribution
694.002 In distribution
682.602 In distribution
6177.4200 In distribution
673.107 Height 7 mm In distribution
6235.0362 In distribution
6235.3350 In distribution
6124.0011 In distribution
646.610 Height 10 mm In distribution
650.114 Length 14 mm In distribution
652.675 In distribution
6128.2275 Height 5 mm In distribution
624.619 In distribution
665.506 Width 14 mm In distribution
664.115 Height 15 mm In distribution
632.650 Width 2.5 mm In distribution
697.705 In distribution
625.405 Outer Diameter 8.5 mm In distribution
6134.0055 Outer Diameter 5.5 mm In distribution
604.809 Height 9 mm In distribution
6194.5101 In distribution
664.113 Width 29 mm In distribution
630.016 In distribution
654.405 In distribution
632.616 In distribution
684.131 Width 18 mm In distribution
608.109 Height 9 mm In distribution
624.615 In distribution
630.326 In distribution
6142.8732 In distribution
602.510 In distribution
6156.0150 Outer Diameter 5 mm In distribution
675.652 Width 26 mm In distribution
6178.5335 In distribution
632.238 Length 80 mm In distribution
6218.8065 Outer Diameter 6.5 mm In distribution
6230.0055 In distribution
6128.2206 Depth 12 mm In distribution
6138.0102 In distribution
6179.9904 In distribution
6101.5120 Length 120 mm In distribution
614.893 Star, SYN In distribution
622.513 Length 26 mm In distribution
6138.1061 Length 60 mm In distribution
654.412 In distribution
6168.1001 In distribution
6235.1358 In distribution
655.216 Outer Diameter 6.5 mm In distribution
665.707 Width 16 mm In distribution
682.648 In distribution
634.602 In distribution
639.011 In distribution
6145.2212 Length 22 mm In distribution
6145.3817 Height 17 mm In distribution
6179.2001 In distribution
622.525 In distribution
6116.3008 In distribution
634.601 In distribution
646.720 Height 20 mm In distribution
665.045 Depth 15 mm In distribution
676.031 Height 11 mm In distribution
650.118 Length 18 mm In distribution
624.306 In distribution
673.117 Height 17 mm In distribution
648.215 In distribution
6128.4206 Height 6 mm In distribution
675.820 Outer Diameter 20 mm In distribution
665.416 Height 6 mm In distribution
610.812 In distribution
646.953 In distribution
6145.9254 Length 22 mm In distribution
6235.1258 In distribution
6178.4045 In distribution
6145.1008 Lordosis 7 Degree In distribution
6149.6800 In distribution
634.406 In distribution
6145.1007 Length 18 mm In distribution
693.106 In distribution
655.124 In distribution
656.144 In distribution
6190.0069 In distribution
664.815 Height 15 mm In distribution
665.052 Height 12 mm In distribution
676.612 Width 39 mm In distribution
606.004 In distribution
6147.1412 Lordosis 20 Degree In distribution
6145.2016 Length 18 mm In distribution
6190.0024 In distribution
673.011 In distribution
684.718 Width 20 mm In distribution
698.131 In distribution
610.805 In distribution
675.863 Height 13 mm In distribution
684.303 In distribution
601.015 In distribution
685.490 In distribution
665.527 Height 7 mm In distribution
675.182 In distribution
6134.0112 Outer Diameter 17.5 mm In distribution
6041.0405 Length 205 mm In distribution
6067.0005 In distribution
6101.5180 Length 180 mm In distribution
676.563 Lordosis 15 Degree In distribution
6257.1019 In distribution
6189.7004 In distribution
610.810 In distribution
6116.1190 Angle 90 ° In distribution
6168.3000 In distribution
601.315 Height 15 mm In distribution
6230.0052 In distribution
671.201 In distribution
675.111 Lordosis 6 Degree In distribution
648.007 Length 600 mm In distribution
671.016 Length 16 mm In distribution
682.202 In distribution
647.047 Outer Diameter 4.7 mm In distribution
602.601 In distribution
626.415 Height 15 mm In distribution
6257.1017 In distribution
6235.1266 In distribution
675.077 Lordosis 10 Degree In distribution
647.801 Outer Diameter 2.5 mm In distribution
663.344 In distribution
651.011 In distribution
6147.2209 Lordosis 12 Degree In distribution
616.001 In distribution
615.303 In distribution
6067.0900 In distribution
685.055 Outer Diameter 5.5 mm In distribution
6136.0410 Height 10 mm In distribution
684.108 Height 8 mm In distribution
6173.1503 In distribution
6156.3025 In distribution
6136.0506 Depth 15 mm In distribution
693.611 In distribution
625.715 Height 15 mm In distribution
6041.0601 Length 162 mm In distribution
685.672 Outer Diameter 1.65 mm In distribution
630.317 In distribution
634.800 In distribution
688.367 In distribution
6142.8731 In distribution
6252.1506 In distribution
6252.7014 In distribution
6170.7001 In distribution
6145.4111 Height 11 mm In distribution
6235.0366 In distribution
632.242 Length 120 mm In distribution
6156.0145 Outer Diameter 4.5 mm In distribution
6041.4306 In distribution
6170.5018 In distribution
684.430 Length 20 mm In distribution
6136.1511 Depth 15 mm In distribution
6128.2482 Angle 7 ° In distribution
679.021 Length 10.7 mm In distribution
6128.2491 In distribution
6145.9256 Length 22 mm In distribution
6136.0432 Width 16 mm In distribution
684.709 Depth 16 mm In distribution
622.001 In distribution
6138.0103 In distribution
6128.2276 Height 6 mm In distribution
685.008 Length 500 mm In distribution
6179.7027 In distribution
608.111 Height 11 mm In distribution
6202.8001 In distribution
647.008 Length 500 mm In distribution
6041.0324 In distribution
6105.2012 Width 17 mm In distribution
602.505 In distribution
632.655 In distribution
675.067 Lordosis 10 Degree In distribution
676.650 In distribution
685.102 Outer Diameter 17 mm In distribution
639.651 In distribution
675.065 Lordosis 10 Degree In distribution
608.117 Height 17 mm In distribution
682.832 In distribution
603.957 In distribution
6136.1206 Depth 12 mm In distribution
6128.2580 Width 18 mm In distribution
6168.7011 In distribution
6173.5105 In distribution
6188.7225 Outer Diameter 0.8 mm In distribution
648.311 In distribution
675.507 Height 6 mm In distribution
6128.1540 Depth 15 mm In distribution
6067.1030 In distribution
6177.3204 Width 2.5 mm In distribution
675.915 Length 150 mm In distribution
665.308 Height 8 mm In distribution
6067.0056 In distribution
6145.3011 Height 11 mm 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
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
Acumed Acumed LLC 1,177

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