Identity
- Trade Name
- ALEUTIAN Cervical FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Trial, Size 11.5x14.5x13 mm, 7° FDA UDI
- Model / Reference
- SP-4255-09 FDA UDI
- Description
- Trial, Size 11.5x14.5x13 mm, 7° FDA UDI
Identifiers
- Catalog Number
- SP-4255-09 FDA UDI
- Primary DI / UDI-DI
- 10888857515758 FDA UDI
- 510(k) Number
- K133614 FDA UDI
- FDA Product Code
- ODP FDA UDIMAX FDA UDIMQP 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Height — 13 Millimeter FDA UDIWidth — 14.5 Millimeter FDA UDIAngle — 7 degree FDA UDILength — 11.5 Millimeter FDA UDI
Category: General internal orthopaedic fixation system implantation kit
The ALEUTIAN Cervical is a comprehensive internal orthopaedic fixation system designed for the placement of an internal fixation device into or onto various types of bones, including limbs, spine, pelvis, or craniomaxillofacial. This reusable device includes a variety of instruments and materials, such as retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors, and is intended for implantation of any type of internal orthopaedic fixation system.
Similar devices
Also classified as General internal orthopaedic fixation system implantation kit.
- Matrixx System — NEXXT SPINE LLC · Class I
- Swedge Pedicle Screw Fixation System — SPINAL RESOURCES INC · Class II
- tangis — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ACUMED — ACUMED LLC · Class I
- OsteoMed — Osteomed Corp. · Class II
- HONOUR™ Spacer System — NEXXT SPINE LLC · Class II
- OsteoMed — Osteomed Corp. · Class II
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
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 eaf87c72-cbf2-4e80-a981-319716807f25 37 fields · synced Jul 25, 2026