Identity
- Trade Name
- Dymaxeon® FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, sterile FDA UDI
- Device Name
- DYMAXEON 5.5 Vertebral ROD Ø5.5X350mm (BLUE) FDA UDI
- Model / Reference
- 05.5 FDA UDI
- Description
- DYMAXEON 5.5 Vertebral ROD Ø5.5X350mm (BLUE) FDA UDI
Identifiers
- Catalog Number
- 06.6427B FDA UDI
- Primary DI / UDI-DI
- 00815500022021 FDA UDI
- FDA Product Code
- MNH FDA UDINKB FDA UDIMNI FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, sterile 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 350 Millimeter FDA UDI
Category: Bone-screw internal spinal fixation system, sterile
Dymaxeon® by Back 2 Basic Direct, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system, sterile.
- Libra Pedicle Screw System — Spinal Balance, Inc. · Class II
- Easyspine — Ldr Spine USA · Class II
- SANTIS™ NON CANNULATED POLYAXIAL PEDICLE SCREW/ DIA.6.5mm/Length40mm -STERILE — Lanterna Medical Technologies · Class II
- Paeon Posterior Cervical Fixation System — Aegis Spine, Inc. · Class II
- Mont Blanc MIS Spinal Systems — Spineway SA · Class II
- ROMEO Posterior Osteosynthesis system — Spineart · Class II
- VERTICALE — Silony Medical GmbH · Class II
- Mont Blanc MIS Spinal Systems — Spineway SA · 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
- Back 2 Basic Direct, Llc
Sources (1)
- FDA UDI 5e120c80-3ac9-4c96-9a72-6e854b10ca64 37 fields · synced May 29, 2026