Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee
FDA 510(k) clearance K253507 · decided 2026-06-02
Clearance details
- K-number
- K253507
- Device name
- Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee
- Applicant
- Orthalign, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-11-03
- Decision date
- 2026-06-02
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- ONN
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.