Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee— 510(k) K253507
Substantially EquivalentOrthalign, Inc.
FDA 510(k) clearance K253507 for Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee, Substantially Equivalent on 2026-06-02. Applicant: Orthalign, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthalign, Inc.
- Product code
- Code ONN
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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