Synergy Disc Implant
by Synergy Spine Solutions Inc. 12 variants
Ref 1077-3360Model Synergy Disc - Large, 6mm, 0 degree
Active
CE MDD
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number+M670107733600H | Date18 Mar 2026 | StatusListed |
| European Union | CE/MDD EUDAMED | NumberB-+M670107733600H +M670107733600H | Date6 Aug 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Synergy Disc
- Generic Name
- Cervical total intervertebral disc prosthesis, modular
- Device Name
- Synergy Disc Implant
- Model / Ref / Catalog
- Synergy Disc - Large, 6mm, 0 degree, 1077-3360
- Primary DI / UDI-DI
- +M670107733600H EUDAMEDM670107733600 GUDID
- Basic UDI-DI
- B-+M670107733600H
- FDA Product Code
- MJO
- EMDN Code
- P09070201 Disc prostheses
- GMDN Term
- Cervical total intervertebral disc prosthesis, modular
- Device Class
- Class IIb EUDAMEDClass III GUDID
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Conditional
- Size
- Angle — 0 degreeHeight — 6 Millimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Primary DI / UDI-DI | +M670107733600H | M670107733600 |
| Device Class | Class IIb | Class III |
Manufacturer details
- EUDAMED SRN
- US-MF-000014165
- Authorised representative
- MedNet EC-REP III GmbH DE-AR-000011191
Other devices from Synergy Spine Solutions Inc.
Properties
Other properties (17)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No