CMORE® CT System; CMORE® CT System Navigated Instruments
FDA 510(k) clearance K252327 · decided 2025-11-12
Clearance details
- K-number
- K252327
- Device name
- CMORE® CT System; CMORE® CT System Navigated Instruments
- Applicant
- Icotec AG
- Decision
- Substantially Equivalent
- Date received
- 2025-07-25
- Decision date
- 2025-11-12
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- NKG
- Device class
- 2
- Regulation number
- 888.3075
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Altstaetten, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.