Identity
- Trade Name
- DENALI® Spinal System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system hook FDA UDI
- Device Name
- Lumbar Laminar Hook, Narrow Size (L) FDA UDI
- Model / Reference
- 101-80011 FDA UDI
- Description
- Lumbar Laminar Hook, Narrow Size (L) FDA UDI
Identifiers
- Catalog Number
- 101-80011 FDA UDI
- Primary DI / UDI-DI
- 10888857007598 FDA UDI
- FDA Product Code
- KWP FDA UDIMNH FDA UDIKWQ FDA UDINKB FDA UDIOSH FDA UDIMNI FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system hook FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI888.3070 FDA UDI888.3060 FDA UDI
- Commercial Distribution
- 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5.5 Millimeter FDA UDI
Category: Bone-screw internal spinal fixation system hook
DENALI® Spinal System by K2m, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone-screw internal spinal fixation system hook.
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- neon³™ OCT spinal stabilization — Ulrich GmbH & Co. KG · 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
- K2m, Inc.
Sources (1)
- FDA UDI 1ce74372-1dff-469d-95ed-3f29554af03e 36 fields · synced May 29, 2026