Streamline® OCT Occipito-Cervico-Thoracic System

Parallel Connector Counter Torque Tube

Registry build 21.09.26
53manufacturers in China registered for this device type
132catalogue 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® OCT Occipito-Cervico-Thoracic 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 2016-09-05
Record revised 2026-02-12 (version 7)

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 2022-12-19

Catalogue Numbers

Catalogue numbers for Streamline® OCT Occipito-Cervico-Thoracic System
Catalogue number Size Status
26-CC-TRANS-ROD Withdrawn
26-FTAP-30-10 Withdrawn
26-FTAP-35-16 Withdrawn
23-TAPSLEEVE Withdrawn
26-YOKEMANPLTR-3 Withdrawn
23-OFFSET Withdrawn
26-SCREWINSRTR-4 Withdrawn
23-40-FDRILL-14 Withdrawn
26-H2H-BENDER Withdrawn
23-SCRWINSRT-S Withdrawn
26-FNLDRIVER Withdrawn
26-OCPGUIDE-6-8 Withdrawn
26-DISTRACTOR Withdrawn
26-COUNTER-T-INLNE Withdrawn
26-FDRILL-35-14 Withdrawn
26-FTAP-40-18 Withdrawn
26-COMPRESSOR Withdrawn
26-OCPFLXDRVR Withdrawn
26-FDRILL-35-16 Withdrawn
23-35-FDRILL-12 Withdrawn
26-FGUIDE Withdrawn
26-OCPSTBDRILL Withdrawn
26-RODTEMP-120 Withdrawn
23-HOOK-L-N Withdrawn
26-RODTEMP2-120 Ø3.2mm, 120mm (L) Withdrawn
26-ROCKER-2 Withdrawn
26-CAPINSRTR-2 Withdrawn
26-JACOBSCHUCK Withdrawn
26-DORSALADJUSTR Withdrawn
26-OCPDRILL-2 Withdrawn
23-RODCUTTER Withdrawn
26-OCPSTBDRVR Withdrawn
23-RATCHET-AO Withdrawn
26-FNLDRIVER-2 Withdrawn
23-35-VDRILL Withdrawn
26-VGUIDE Withdrawn
26-COUNTER-T-CONN Withdrawn
23-NUTDRIVER Withdrawn
26-FTAP-35-18 Withdrawn
26-COUNTER-T-2 Withdrawn
26-H2H-XLINK-DRVR Withdrawn
26-COUNTER-T Withdrawn
26-RATCHET-AO Withdrawn
26-RODCUTTER-1 Withdrawn
26-OCP-TORQUE-AO Withdrawn
26-OCPSTBTAP Withdrawn
26-FTAP-30-18 Withdrawn
26-VDRILL-35 Withdrawn
26-FTAP-30-16 Withdrawn
23-REDUCER Withdrawn
26-OCPCOUNTER-T Withdrawn
26-FGUIDE-G Withdrawn
23-35-FDRILL-14 Withdrawn
23-DRILLGUIDE Withdrawn
26-CAPINSRTR Withdrawn
26-DISTRACTOR-PRL Withdrawn
26-OCPTAP Withdrawn
26-R2R-XLINK-DRVR Withdrawn
26-FTAP-30-12 Withdrawn
23-YOKEMAN Withdrawn
26-OCPGUIDE-14-16 Withdrawn
23-HOOK-S-N Withdrawn
26-DISTRACTOR-SM Withdrawn
23-C-FINDER Withdrawn
23-SWIVMAN Withdrawn
26-FTAP-35-12 Withdrawn
26-FTAP-35-10 Withdrawn
23-45-DRILL Withdrawn
26-FTAP-45 Withdrawn
26-SCREWINSRTR Withdrawn
26-OCPDRILL Withdrawn
26-REDUCER Withdrawn
26-OCPDRVR Withdrawn
23-HOOKHOLDER Withdrawn
26-S-FINDER Withdrawn
26-SCREWINSRTR-2 Withdrawn
23-SETSCREWINS Withdrawn
26-P-HANDLE Withdrawn
26-REDUCER-2 Withdrawn
23-CRSSLNKSLV Withdrawn
23-VAR-GUIDE Withdrawn
23-40-FDRILL-12 Withdrawn
26-RODTEMP2-240 Ø3.2mm, 240mm (L) Withdrawn
26-AWL-G Withdrawn
26-FDRILL-35-18 Withdrawn
26-YOKEMANPLTR Withdrawn
26-OCPFLXDRILL-2 Withdrawn
26-FTAP-40-16 Withdrawn
23-OFFSETCTT Withdrawn
26-REDUCER-3 Withdrawn
26-OCPFLXTAP Withdrawn
26-MANIPULATOR Withdrawn
26-COMPRESSOR-SM Withdrawn
26-COUNTER-T-3 Withdrawn
26-COUNTER-T-XLINK Withdrawn
26-COMPRESSOR-PRL Withdrawn
26-RODCUTTER Withdrawn
23-S-PROBE Withdrawn
26-FTAP-30-14 Withdrawn
26-FDRILL-35-10 Withdrawn
26-OCPSTBDRILL-2 Withdrawn
23-HOOK-R-N Withdrawn
26-FTAP-35-14 Withdrawn
23-C-TORQUE-P Withdrawn
26-OCP-CNTRTORQ Withdrawn
26-OCPFLXDRILL Withdrawn
26-FTAP-40-14 Withdrawn
26-FTAP-40-12 Withdrawn
23-RODHOLDER Withdrawn
23-RODPUSHER Withdrawn
26-BALLTIPPRBE Withdrawn
26-DEPTH-GAGE Withdrawn
26-FDRILL-35-12 Withdrawn
23-COUNTER-T Withdrawn
26-RODCUTTER-2 Withdrawn
26-TORQUE-AO-23 23 in-lb Withdrawn
26-OCPSTFLDRVR Withdrawn
26-OCPTABBREAKER Withdrawn
26-VGUIDE-2 Withdrawn
23-S-FINDER Withdrawn
26-OCPRATCHET Withdrawn
26-FTAP-40-10 Withdrawn
26-YOKEMANPLTR-2 Withdrawn
26-CC-TRANS-ROD-XL Withdrawn
23-TORQUE-AO Withdrawn
23-40-VDRILL Withdrawn
26-C-FINDER Withdrawn
26-DEBURRER Withdrawn
26-OCPGUIDE-10-12 Withdrawn
724-188 Withdrawn
26-RODTEMP-240 Withdrawn
23-DEPTH-GAGE 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