Traumaone
Ref SP-2917
Traumaone (SP-2917) is a Class I device made by Biomet Microfixation, Inc, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 889024Z1K2), active as of 7 Nov 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number889024Z1K2 00888233020343 | Date27 Oct 2026 | StatusActive |
Official records
- EUDAMED public site 889024Z1K2
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Mandibular Instruments
- Model / reference
- SP-2917
- Primary DI / UDI-DI
- 00888233020343
- Basic UDI-DI
- 889024Z1K2
- Direct marketing DI
- 00888233020343
- EMDN code
- L091002 Instruments for processing materials for osteosynthesis, reusable
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- US-MF-000001169
- Authorised representative
- Biomet Global Supply Chain Center B.V. NL-AR-000000422
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