FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K2M Navigation Instruments
K Number: K171321
·
Decision Aug 30, 2017
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
16
Review Days
118
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Basic Information
- Device Name
- K2M Navigation Instruments
- K Number
- K171321
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- K2m
- Date Received
- May 4, 2017
- Decision Date
- August 30, 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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|---|---|---|---|
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| K160125 | Cascadia Interbody System | Apr 22, 2016 | Substantially Equivalent |