Identity
- Trade Name
- EVEREST® Spinal System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system rod FDA UDI
- Device Name
- Contoured Deformity Rod Size Ø6.0x375 mm Dual Hex Ti FDA UDI
- Model / Reference
- 2901-B660375 FDA UDI
- Description
- Contoured Deformity Rod Size Ø6.0x375 mm Dual Hex Ti FDA UDI
Identifiers
- Catalog Number
- 2901-B660375 FDA UDI
- Primary DI / UDI-DI
- 10888857271418 FDA UDI
- FDA Product Code
- KWP FDA UDIKWQ FDA UDIMNI FDA UDIOSH FDA UDINKB FDA UDIMNH FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system rod FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI888.3060 FDA UDI888.3070 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 375 Millimeter FDA UDIOuter Diameter — 6 Millimeter FDA UDI
EVEREST® 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 7891fbc3-f2c4-49ee-a45a-66687746abf5 37 fields · synced Jun 1, 2026