Symphony

SYMPHONY OCT SYSTEM CORTICAL FIX POLYAXIAL SCREW REDUCTION CANNULATED diameter 4.0 Rod, 5.0X34mm 3.5 and 4.0

Registry build 21.09.26
11manufacturers in China registered for this device type
312catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (5), Shandong (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KWP
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
APS Materials Suzhou Suzhou Jiangsu Contract manufacturer 18
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Suzhou Jiangsu Manufacturer 34
Double Medical Technology Inc. Xiamen Fujian Contract manufacturer 14
Zhejiang Decans Medical Devices Co., Ltd. Jiaxing Zhejiang Manufacturer 10

Record

Regulatory record for Symphony
Listed by Medos International Sàrl, Switzerland
FDA product code KWP
Device type Appliance, Fixation, Spinal Interlaminal
Device class Class 2
Regulation 21 CFR 888.3050
510(k) K192646
Record published 2020-07-01
Record revised 2025-07-14 (version 5)

Specifications

Specifications
MRI safety MR Conditional
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Symphony
Catalogue number Size Status
1020-45-310S In distribution
1020-15-112S In distribution
1020-35-936 In distribution
1020-63-030 In distribution
1020-40-138S In distribution
1020-35-132 In distribution
1020-35-740 In distribution
1020-19-001 In distribution
1020-50-232 In distribution
1020-35-338 In distribution
1020-40-808 In distribution
1020-19-001S In distribution
1020-50-222S In distribution
1020-35-324S In distribution
1020-35-732S In distribution
1020-35-118S In distribution
1020-35-120 In distribution
1020-63-040S In distribution
1020-96-600S In distribution
1020-45-222 In distribution
1020-50-228 In distribution
1020-35-530S In distribution
1020-35-834 In distribution
1020-55-430S In distribution
1020-84-600S In distribution
1020-15-111S In distribution
1020-35-918 In distribution
1020-55-450S In distribution
1020-45-108S In distribution
1020-40-620S In distribution
1020-26-105 In distribution
1020-45-114S In distribution
1020-40-624S In distribution
1020-40-116S In distribution
1020-35-724S In distribution
1020-40-328 In distribution
1020-26-102 In distribution
1020-45-250S In distribution
1020-26-106 In distribution
1020-63-090 In distribution
1020-30-126 In distribution
1020-30-118 In distribution
1020-64-055 In distribution
1020-40-324 In distribution
1020-26-102S In distribution
1020-26-212 In distribution
1020-30-108 In distribution
1020-63-055 In distribution
1020-25-212 In distribution
1020-24-003S In distribution
1020-35-134 In distribution
1020-25-112S In distribution
1020-64-055S In distribution
1020-55-222S In distribution
1020-35-734S In distribution
1020-26-104 In distribution
1020-35-736 In distribution
1020-55-236 In distribution
1020-50-434 In distribution
1020-26-212S In distribution
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1020-40-830 In distribution
1020-45-428 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Invictus Alphatec Spine, Inc. 5,422
ReLine Nuvasive, Inc. 4,439
CD Horizon® Spinal System Medtronic Sofamor Danek, Inc. 3,188
Creo Globus Medical, Inc. 1,992
Apex Spine System Spinecraft LLC 1,319
LnK Spinal Fixation System L&K Biomed Co., Ltd. 1,271
Perla ® TL Spineart SA 1,035
Astra Spine System Spinecraft LLC 1,003
LineSider Highridge Medical, LLC 948
Apex-DL Spine System Spinecraft LLC 909
Revere Globus Medical, Inc. 875
AccelFix Spinal Fixation System L&K Biomed Co., Ltd. 841

Showing 12 of 536. All products under Appliance, Fixation, Spinal Interlaminal

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