Identity
- Trade Name
- ALEUTIAN Cervical FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Trial, Size 11.5x14.5x5 mm, 7° FDA UDI
- Model / Reference
- SP-4255-01 FDA UDI
- Description
- Trial, Size 11.5x14.5x5 mm, 7° FDA UDI
Identifiers
- Catalog Number
- SP-4255-01 FDA UDI
- Primary DI / UDI-DI
- 10888857515673 FDA UDI
- 510(k) Number
- K133614 FDA UDI
- FDA Product Code
- ODP FDA UDIMQP FDA UDIMAX FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI888.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
- Angle — 7 degree FDA UDILength — 11.5 Millimeter FDA UDIHeight — 5 Millimeter FDA UDIWidth — 14.5 Millimeter FDA UDI
Category: General internal orthopaedic fixation system implantation kit
ALEUTIAN Cervical by K2m, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General internal orthopaedic fixation system implantation kit.
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- OsteoMed — Osteomed Corp. · Class II
- HONOUR™ Spacer System — NEXXT SPINE LLC · Class II
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Cleared under the same submission
K133614 also covers:
- ALEUTIAN Cervical — K2M, INC.
- ALEUTIAN Cervical — K2M, INC.
- ALEUTIAN Cervical — K2M, INC.
- ALEUTIAN Cervical — K2M, INC.
- ALEUTIAN Cervical — K2M, INC.
- ALEUTIAN Cervical — K2M, INC.
- ALEUTIAN Cervical — K2M, INC.
- ALEUTIAN Cervical — K2M, INC.
- ALEUTIAN Cervical — K2M, INC.
- ALEUTIAN Cervical — K2M, INC.
- ALEUTIAN® Interbody Systems — K2M, INC.
- ALEUTIAN® Interbody Systems — K2M, INC.
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 3112933b-d61d-40f3-b0fe-412e80da197c 37 fields · synced May 30, 2026