Identity
- Trade Name
- Dynesys® FDA UDI
- Generic Name
- Spinal dynamic-stabilization system FDA UDI
- Device Name
- DYNESYS Pedicle+Set Screw 7.2x50 FDA UDI
- Model / Reference
- 01.03717.250 FDA UDI
- Description
- DYNESYS Pedicle+Set Screw 7.2x50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889024283855 FDA UDI
- FDA Product Code
- NQP FDA UDI
- GMDN Term
- Spinal dynamic-stabilization system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 50 Millimeter FDA UDIOuter Diameter — 7.2 Millimeter FDA UDI
Category: Spinal dynamic-stabilization system
Dynesys® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal dynamic-stabilization system.
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- DSS Pedicle screw set, Ø8.0 x 50mm — Paradigm Spine, LLC · Class II
- DSS Pedicle screw set, Ø8.0 x 60mm — Paradigm Spine, LLC · Class II
- DSS HP Polyaxial pedicle screw set, Ø5 x 60mm — Paradigm Spine, LLC · Class II
- DSS Pedicle screw set, Ø5.0 x 45mm — Paradigm Spine, LLC · Class II
- DSS HP Polyaxial pedicle screw set, Ø8 x 45mm — Paradigm Spine, LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Zimmer, Inc.
Sources (1)
- FDA UDI a7c182e1-ec2a-4d3b-ae6d-aa0861e3a159 35 fields · synced May 30, 2026