Identity
- Trade Name
- ALEUTIAN® Interbody Systems FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Cervical Inserter, Size 14 mm FDA UDI
- Model / Reference
- SP-3182-01 FDA UDI
- Description
- Cervical Inserter, Size 14 mm FDA UDI
Identifiers
- Catalog Number
- SP-3182-01 FDA UDI
- Primary DI / UDI-DI
- 10888857430907 FDA UDI
- 510(k) Number
- K133614 FDA UDI
- FDA Product Code
- ODP FDA UDIMAX FDA UDIMQP FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable 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
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
ALEUTIAN® Interbody Systems by K2m, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.
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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 Cervical — 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 098539c9-22ed-4934-b788-994485621f9b 36 fields · synced May 30, 2026