FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KneeAlign 2 System
K Number: K163379
·
Decision Mar 2, 2017
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
14
Review Days
91
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Basic Information
- Device Name
- KneeAlign 2 System
- K Number
- K163379
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthalign, Inc.
- Date Received
- December 1, 2016
- Decision Date
- March 2, 2017
- Product Code
- OLO
- Advisory Committee
- Neurology
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
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Other Clearances by Orthalign, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253507 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee | Jun 2, 2026 | Substantially Equivalent |
| K242616 | Lantern® Hip | Oct 3, 2024 | Substantially Equivalent |
| K200892 | Harvey(R) Surgical Assistant | Jun 18, 2020 | Substantially Equivalent |
| K200642 | OrthAlign Plus System | Apr 10, 2020 | Substantially Equivalent |
| K172462 | OrthAlign Plus System | Nov 22, 2017 | Substantially Equivalent |
| K171780 | OrthAlign Plus System | Jul 11, 2017 | Substantially Equivalent |
| K162962 | OrthAlign Plus System | Jan 23, 2017 | Substantially Equivalent |
| K153237 | OrthAlign Plus System | Mar 1, 2016 | Substantially Equivalent |
| K140331 | ORTHALIGN PLUS SYSTEM | Jun 10, 2014 | Substantially Equivalent |
| K130387 | ORTHOALIGN PLUS SYSTEM | Nov 8, 2013 | Substantially Equivalent |