FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K2M Navigation Instruments
K Number: K171556
·
Decision Jan 16, 2018
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
16
Review Days
231
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Basic Information
- Device Name
- K2M Navigation Instruments
- K Number
- K171556
- 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 30, 2017
- Decision Date
- January 16, 2018
- 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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| K Number | Device Name | ||
|---|---|---|---|
| K182182 | YUKON OCT Spinal System | Nov 15, 2018 | Substantially Equivalent |
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| K172941 | CASCADIA Interbody System | Feb 12, 2018 | Substantially Equivalent |
| K173508 | Everest Spinal System | Jan 9, 2018 | Substantially Equivalent |
| K171704 | CAPRI Corpectomy Cage System | Aug 31, 2017 | Substantially Equivalent |
| K171321 | K2M Navigation Instruments | Aug 30, 2017 | Substantially Equivalent |
| K170055 | CAPRI Corpectomy Cage System | Apr 13, 2017 | Substantially Equivalent |
| K163364 | MOJAVE Expandable Interbody System | Mar 15, 2017 | Substantially Equivalent |
| K153526 | Pyrenees Cervical Plate System | Apr 27, 2016 | Substantially Equivalent |
| K160125 | Cascadia Interbody System | Apr 22, 2016 | Substantially Equivalent |