ALEUTIAN® Interbody Systems 3201-90288
by VB Spine LLC EUDAMEDGUDID
Active
Ref 3201-90288Model 08858251006171TA
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number08858251006171TA | Date30 Aug 2026 | StatusActive |
| United States | GUDID listing GUDID | Number10888857059283 | Date16 Sep 2016 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Recalls
No FDA recalls on record, checked 23 Oct 2026.
Specification
- Trade Name
- ALEUTIAN® Interbody Systems
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable
- Device Name
- Aleutian: Inserter
- Model / Ref / Catalog
- 3201-90288, 08858251006171TA
- Primary DI / UDI-DI
- 10888857059283
- Basic UDI-DI
- 08858251006171TA
- Direct Marketing DI
- 10888857059283
- FDA Product Code
- ODP, MQP, MAX, OVD
- EMDN Code
- L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 888.3080, 888.3060
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Other devices from VB Spine LLC
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: No
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No