ALEUTIAN Interbody Systems
FDA UDIEUDAMEDClass I (US FDA UDI)
by K2m, Inc.
Identity
- Trade Name
- ALEUTIAN® Interbody Systems EUDAMEDALEUTIAN Interbody Systems FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Aleutian: Scraper EUDAMEDEndplate Scraper Size 28x14 mm, 6° FDA UDI
- Model / Reference
- 5303-90102 EUDAMEDFDA UDI08858251006170T8 EUDAMED
- Description
- Endplate Scraper Size 28x14 mm, 6° FDA UDI
Identifiers
- Catalog Number
- 5303-90102 FDA UDI
- Primary DI / UDI-DI
- 10888857111455 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858251006170T8 EUDAMED
- Direct Marketing DI
- 10888857111455 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0901 ORTHOPAEDIC SURGERY SPOONS AND CURETTES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
ALEUTIAN Interbody Systems by K2m, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- K2m, Inc.
Sources (2)
- FDA UDI 3505852c-6434-472b-a4c8-a3e471950c5a 35 fields · synced Oct 10, 2026
- EUDAMED 54b2a359-4111-4eef-871c-bfca90310684 61 fields · synced Oct 9, 2026