Spinal Instrument
by Medos International SARL 44 variants
Ref 202916CModel PLIF SG Osteotomes
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0705034a000545T 10705034240589 | Date15 Aug 2025 | StatusActive |
| United States | GUDID listing GUDID | Number10705034240589 | Date27 Dec 2016 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Orthopaedic osteotome
- Device Name
- PLIF SG Osteotome
- Model / Ref / Catalog
- PLIF SG Osteotomes, 202916C
- Primary DI / UDI-DI
- 10705034240589
- Basic UDI-DI
- 0705034a000545T
- Direct Marketing DI
- 10705034240589
- FDA Product Code
- HWM
- EMDN Code
- L090401 Orthopaedic surgery osteotomes, reusable
- GMDN Term
- Orthopaedic osteotome
- Device Class
- Class I
- Regulation Number
- 878.4800
- EU market of registration
- Belgium
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Manufacturer details
- EUDAMED SRN
- CH-MF-000014268
- Authorised representative
- DePuy Ireland UC IE-AR-000009328
Other devices from Medos International SARL
Properties
Other properties (19)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Reprocessed: 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
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No