Streamline® TL Spinal Fixation System

Pedicle Finder, Curved, Small, Square TIP

Registry build 21.09.26
53manufacturers in China registered for this device type
88catalogue 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 Streamline® TL Spinal Fixation System
Listed by Pioneer Surgical Technology, Inc., United States
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2018-09-24
Record revised 2026-01-30 (version 9)

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, expiry date
Distribution end date 2024-05-26

Catalogue Numbers

Catalogue numbers for Streamline® TL Spinal Fixation System
Catalogue number Size Status
02-REDUCER Withdrawn
02-MANIPANGLED Withdrawn
724-986 Withdrawn
02-C-TAP-85 Withdrawn
02-RET-CLIP Withdrawn
02-TAP-SLEEVE Withdrawn
725-160 Withdrawn
02-GRIPREDUCER Withdrawn
724-177 Withdrawn
10-MARKER-90 Withdrawn
10-DEBURRER Withdrawn
02-TOWER Withdrawn
723-405 Withdrawn
02-S-FINDER-T Withdrawn
724-987 Withdrawn
02-C-TAP-75 Withdrawn
723-258 Withdrawn
02-DEROTATOR Withdrawn
02-RS-INSERTER-C Withdrawn
724-863 Withdrawn
02-TOWERDRIVER Withdrawn
02-CONNECT-BAR-250 Withdrawn
725-095 Withdrawn
723-264 Withdrawn
10-SFINDER-DB-L Withdrawn
724-378 Withdrawn
10-SBALLTIP Withdrawn
725-014 Withdrawn
02-CONNECT-BAR-350 Withdrawn
02-C-TAP-65 Withdrawn
724-200 Withdrawn
722-371 Withdrawn
724-376 Withdrawn
10-RPHANDLE Withdrawn
02-RAPIDREDUCR Withdrawn
02-RS-C-TORQUE Withdrawn
10-CBALLTIP Withdrawn
723-945 Withdrawn
02-RR-HANDLE Withdrawn
723-242 Withdrawn
724-630 Withdrawn
02-S-FINDER-L Withdrawn
02-ELEVATOR-L Withdrawn
02-TL-HANDLE Withdrawn
723-075 Withdrawn
724-001 Withdrawn
723-961 Withdrawn
725-161 Withdrawn
02-CONNECT-BAR-400 Withdrawn
725-096 Withdrawn
10-CFINDER-SM-S Withdrawn
10-PUSHER Withdrawn
725-073 Withdrawn
02-RS-RET-CAP Withdrawn
10-RODTEMPLATE Withdrawn
02-CONNECT-R Withdrawn
02-C-FINDER-T Withdrawn
724-202 Withdrawn
02-C-FINDER-L Withdrawn
724-211 Withdrawn
725-162 Withdrawn
02-CONNECT-L Withdrawn
724-377 Withdrawn
724-379 Withdrawn
02-CONNECT-BAR-300 Withdrawn
10-GRIPPER-S Withdrawn
02-SCREWINSRTR-C Withdrawn
02-CONNECT-C Withdrawn
02-CONNECT-BAR-150 Withdrawn
10-RODFORCEP-S Withdrawn
02-RODGRIPPER Withdrawn
10-SFINDER-LE-L Withdrawn
10-SBALLTIP-R Withdrawn
02-C-TAP-55 Withdrawn
722-331 Withdrawn
02-CONNECT-BAR-200 Withdrawn
02-HOOKPUSHER Withdrawn
02-C-TAP-45 Withdrawn
10-DISTRACTOR Withdrawn
723-490 Withdrawn
02-ADJUSTER Withdrawn
10-TLHANDLE Withdrawn
725-132 Withdrawn
723-259 Withdrawn
10-PHANDLE Withdrawn
02-C-TAP-40 Withdrawn
10-SWIZZLESTIK Withdrawn
10-RTHANDLE 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