Identity
- Trade Name
- DENALI® Spinal System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system rod FDA UDI
- Device Name
- Straight Deformity Rod, Hex Size Ø5.5x400 mm, Ti FDA UDI
- Model / Reference
- 101-A55400 FDA UDI
- Description
- Straight Deformity Rod, Hex Size Ø5.5x400 mm, Ti FDA UDI
Identifiers
- Catalog Number
- 101-A55400 FDA UDI
- Primary DI / UDI-DI
- 10888857011526 FDA UDI
- FDA Product Code
- MNI FDA UDIMNH FDA UDIKWP FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system rod FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5.5 Millimeter FDA UDILength — 400 Millimeter FDA UDI
DENALI® Spinal System by K2m, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- K2m, Inc.
Sources (1)
- FDA UDI 9f48a564-1d9a-4ce4-b258-22d549c095c9 37 fields · synced May 31, 2026