FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHALIGN PLUS SYSTEM
K Number: K140331
·
Decision Jun 10, 2014
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
14
Review Days
120
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Basic Information
- Device Name
- ORTHALIGN PLUS SYSTEM
- K Number
- K140331
- 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
- February 10, 2014
- Decision Date
- June 10, 2014
- 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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| K163379 | KneeAlign 2 System | Mar 2, 2017 | Substantially Equivalent |
| K162962 | OrthAlign Plus System | Jan 23, 2017 | Substantially Equivalent |
| K153237 | OrthAlign Plus System | Mar 1, 2016 | Substantially Equivalent |
| K130387 | ORTHOALIGN PLUS SYSTEM | Nov 8, 2013 | Substantially Equivalent |