Identity
- Trade Name
- DENALI® Spinal System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system hook FDA UDI
- Device Name
- Lumbar Laminar Hook, Standard Size (L) FDA UDI
- Model / Reference
- 101-80013-SG FDA UDI
- Description
- Lumbar Laminar Hook, Standard Size (L) FDA UDI
Identifiers
- Catalog Number
- 101-80013-SG FDA UDI
- Primary DI / UDI-DI
- 10888857007680 FDA UDI
- FDA Product Code
- KWP FDA UDINKB FDA UDIKWQ FDA UDIMNH FDA UDIMNI FDA UDIOSH 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
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
Similar devices
Also classified as Bone-screw internal spinal fixation system hook.
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- TSRH® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- ReLine — Nuvasive, Inc. · Class II
- COSY — SIGNUS Medizintechnik GmbH · Class II
- 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 911160a9-1c73-4765-9335-42880a224256 36 fields · synced May 30, 2026