Identity
- Trade Name
- EVEREST® Spinal System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system hook FDA UDI
- Device Name
- Laminar Hook, Narrow Size (S) FDA UDI
- Model / Reference
- 2901-80037 FDA UDI
- Description
- Laminar Hook, Narrow Size (S) FDA UDI
Identifiers
- Catalog Number
- 2901-80037 FDA UDI
- Primary DI / UDI-DI
- 10888857039476 FDA UDI
- FDA Product Code
- NKB FDA UDIOSH FDA UDIMNI FDA UDIKWP FDA UDIMNH FDA UDIKWQ FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system hook FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 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
Category: Bone-screw internal spinal fixation system hook
EVEREST® 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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- 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 30988e56-07fa-4572-a64c-b12d312e934b 36 fields · synced May 30, 2026