ReLine

RELINE Trauma Pile Driver, Double Barrel

Registry build 21.09.26
53manufacturers in China registered for this device type
1,208catalogue 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 ReLine
Listed by Nuvasive, Inc., United States
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2018-09-24
Record revised 2025-06-11 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date, manufacturing date, serial number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for ReLine
Catalogue number Size Status
10000285 In distribution
10000152 In distribution
10000862 In distribution
10000796 In distribution
3990043 In distribution
3890036 In distribution
D1628720 In distribution
10000404 In distribution
10000315 In distribution
3790049 In distribution
1200009 In distribution
24470020P In distribution
10000718 In distribution
10000314 In distribution
10001121 In distribution
24270090 In distribution
24350080 In distribution
10000784 In distribution
10001715 In distribution
10000333 In distribution
24370095 In distribution
24470085P In distribution
11001217 In distribution
3995001 In distribution
3990006 In distribution
3990014 In distribution
10000682 In distribution
3790012 In distribution
10000866 In distribution
10000726 In distribution
2200611 In distribution
10000171 In distribution
10001003 In distribution
10000960 In distribution
10000372 In distribution
10000293 In distribution
3890019 In distribution
10000562 In distribution
10001120 In distribution
10000699 In distribution
3990022 In distribution
10001702 In distribution
D10000328 In distribution
10001306 In distribution
10000204 In distribution
1200010 In distribution
3793001 In distribution
10000270 In distribution
11001227 In distribution
24450065P In distribution
10001052 In distribution
10000203 In distribution
10000767 In distribution
10000894 In distribution
10001710 In distribution
10000363 In distribution
D11001051 In distribution
3890002 In distribution
10000067 In distribution
1778558P In distribution
10000165 In distribution
3790027 In distribution
10000007 In distribution
10000341 In distribution
10001026 In distribution
1200021 In distribution
10000344 In distribution
24280035 In distribution
3890023 In distribution
10000350 In distribution
10001286 In distribution
10000756 In distribution
10001302 In distribution
10000551 In distribution
24280045 In distribution
10001277 In distribution
10000294 In distribution
10000614 In distribution
1200033 In distribution
10000620 In distribution
11000656 In distribution
10000410 In distribution
1604700 In distribution
10000187 In distribution
10001742 In distribution
10001118 In distribution
10001718 In distribution
3790260 In distribution
10000188 In distribution
24470050P In distribution
D2400150 In distribution
10000860 In distribution
10000834 In distribution
10000901 In distribution
10000146 In distribution
11001213 In distribution
1200016 In distribution
10001323 In distribution
10000021 In distribution
11000712 In distribution
10000395 In distribution
24270095 In distribution
D10000939 In distribution
3995045 In distribution
11000717 In distribution
10001170 In distribution
24450055P In distribution
10000896 In distribution
10001283 In distribution
10000035 In distribution
11000682 In distribution
10001133 In distribution
24280085 In distribution
24350020 In distribution
3990400 In distribution
10001223 In distribution
10000547 In distribution
3790265 In distribution
10000855 In distribution
1200037 In distribution
10001230 In distribution
2200512 In distribution
10000774 In distribution
10000797 In distribution
10000174 In distribution
10000385 In distribution
24370030 In distribution
10000890 In distribution
10000572 In distribution
10000900 In distribution
2200610 In distribution
10000423 In distribution
1200020 In distribution
10001039 In distribution
10000460 In distribution
24280060 In distribution
1606860 In distribution
10000605 In distribution
10001700 In distribution
24250050 In distribution
1200035 In distribution
11000779 In distribution
24470105P In distribution
10000768 In distribution
3890013 In distribution
10001298 In distribution
24270110 In distribution
1729023 In distribution
2200614 In distribution
1200028 In distribution
3790145 In distribution
10000304 In distribution
1200014 In distribution
11000746 In distribution
24280120 In distribution
1200013 In distribution
3990071 In distribution
10000476 In distribution
10001203 In distribution
10000690 In distribution
24250035 In distribution
24370120 In distribution
11000459 In distribution
10000780 In distribution
10000192 In distribution
10001701 In distribution
24270035 In distribution
3890352 In distribution
3790130 In distribution
24370035 In distribution
10000722 In distribution
1200046 In distribution
24370075 In distribution
10000076 In distribution
10000959 In distribution
11000458 In distribution
24370070 In distribution
3790053 In distribution
11000718 In distribution
10001722 In distribution
3790255 In distribution
D10000745 In distribution
10001047 In distribution
24250075 In distribution
1200041 In distribution
3890007 In distribution
1200040 In distribution
3890003 In distribution
10000674 In distribution
D10000828 In distribution
3790011 In distribution
10000844 In distribution
3990340 In distribution
24280040 In distribution
11000426 In distribution
3996005 In distribution
10000037 In distribution
10000666 In distribution
3890353 In distribution
11001214 In distribution
10000685 In distribution
24280025 In distribution
10001709 In distribution
10000329 In distribution
24280050 In distribution
10000577 In distribution
10000695 In distribution
10001748 In distribution
3790135 In distribution
10000326 In distribution
10000914 In distribution
D10000937 In distribution
3890027 In distribution
10001014 In distribution
1200026 In distribution
10000475 In distribution
10000022 In distribution
24450040P In distribution
10000691 In distribution
1200025 In distribution
24250110 In distribution
10000911 In distribution
D10000105 In distribution
24350085 In distribution
2400006 In distribution
24280110 In distribution
3796040 In distribution
D10001053 In distribution
10000554 In distribution
10000377 In distribution
3990020 In distribution
24280070 In distribution
10001759 In distribution
10001303 In distribution
10000552 In distribution
24370040 In distribution
10000086 In distribution
10001267 In distribution
1200011 In distribution
10000247 In distribution
11000428 In distribution
3990026 In distribution
10000017 In distribution
1601750 In distribution
24250065 In distribution
3890024 In distribution
10001143 In distribution
10000724 In distribution
10000704 In distribution
10001723 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
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