Zeta Navigation System (ZNS131-US)
FDA 510(k) clearance K251927 · decided 2025-10-10
Clearance details
- K-number
- K251927
- Device name
- Zeta Navigation System (ZNS131-US)
- Applicant
- Zeta Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-23
- Decision date
- 2025-10-10
- Days to decision
- 109 days
- Clearance type
- Special
- Product code
- SGE
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Zeta Surgical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.