OsteoSight™ Hip (v1)
FDA 510(k) clearance K251408 · decided 2025-09-02
Clearance details
- K-number
- K251408
- Device name
- OsteoSight™ Hip (v1)
- Applicant
- Naitive Technologies, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-05-06
- Decision date
- 2025-09-02
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- SAO
- Device class
- 2
- Regulation number
- 892.1171
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Cambridge, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.