Symphony OCT System - Rods
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- SYMPHONY OCT SYSTEM EUDAMEDSYMPHONY FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system rod FDA UDI
- Device Name
- RODS FOR CERVICAL FIXATION SYSTEM EUDAMEDSYMPHONY OCT SYSTEM PRE-CUT PRE-LORDOSED ROD TITANIUM ALLOY diameter4.0X85mm FDA UDI
- Model / Reference
- SYMPHONY OCT SYSTEM - RODS EUDAMED1020-64-085 EUDAMEDFDA UDI
- Description
- SYMPHONY OCT SYSTEM PRE-CUT PRE-LORDOSED ROD TITANIUM ALLOY diameter4.0X85mm FDA UDI
Identifiers
- Catalog Number
- 102064085 FDA UDI
- Primary DI / UDI-DI
- 10705034511900 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705034a0023867 EUDAMED
- FDA Product Code
- KWP FDA UDINKG FDA UDI
- EMDN Code
- P09070301 CERVICAL FIXATION SYSTEMS EUDAMED
- GMDN Term
- Bone-screw internal spinal fixation system rod FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3050 FDA UDI888.3075 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Cervical spine immobilization system, single-use
The Symphony OCT System - Rods is an implantable cervical fixation device designed for spinal stabilization. It functions as part of a rod-based system to provide structural support in cervical spine procedures.
Supplied non-sterile and intended for reuse after appropriate sterilization by the healthcare facility. The device includes suture attachment points (SUTURES: 1) and is identified by reference 1020-64-085. It is classified as Class IIb and authorized under FDA 510(k) and MDR regulations.
Similar devices
Also classified as Cervical spine immobilization system, single-use.
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- PMT® Halo Systems — Pmt Corp. · Class II
- PMT® Halo Systems — Pmt Corp. · Class II
- MATRIS - Cervical plates and screw — NovaSpine · Class IIb
- PMT® Halo Systems — Pmt Corp. · Class II
- PCF Rod — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- TST Spinal System — TST RAKOR VE TIBBİ ALETLER SAN.VE TİC.LTD.ŞTİ. · Class IIb
- PMT® Halo Systems — Pmt Corp. · Class II
Frequently asked questions
Is the Symphony OCT System - Rods sterile when supplied?
No, the device is supplied non-sterile (STERILE: 0) and must be sterilized by the healthcare provider before implantation.
Can the Symphony OCT System - Rods be reused after a procedure?
No, the device is designed for single use only (REUSABLE: 0) and should not be reprocessed or reused after implantation.
Does the Symphony OCT System - Rods include suture attachment features?
Yes, the device includes suture attachment points as indicated by the SUTURES: 1 specification, allowing for secure fixation during surgical procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192646 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K233366 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K192014 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K203319 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K181949 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0705034a0023867 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medos International SARL
- EUDAMED SRN
- CH-MF-000014268
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (3)
- EUDAMED 2310f074-4381-4fda-81f2-93e7a5ae7fa7 61 fields · synced Sep 18, 2026
- FDA UDI f59bed56-b324-4e9b-80c7-cd439226b71b 36 fields · synced May 30, 2026
- FDA 510(k) K192646 1 fields · synced May 18, 2026