Identity
- Trade Name
- ALEUTIAN Interbody Systems FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Lordotic Trial Size 5x20x60 mm 8° FDA UDI
- Model / Reference
- SP-2477-01 FDA UDI
- Description
- Lordotic Trial Size 5x20x60 mm 8° FDA UDI
Identifiers
- Catalog Number
- SP-2477-01 FDA UDI
- Primary DI / UDI-DI
- 10888857391741 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
- Not 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
ALEUTIAN Interbody Systems 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- K2m, Inc.
Sources (1)
- FDA UDI ab43091b-2e22-48aa-8595-3e8dd3850fe2 36 fields · synced May 31, 2026