FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
YUKON OCT Spinal System
K Number: K182182
·
Decision Nov 15, 2018
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
117
Applicant Total
16
Review Days
94
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Basic Information
- Device Name
- YUKON OCT Spinal System
- K Number
- K182182
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3075
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- K2m
- Date Received
- August 13, 2018
- Decision Date
- November 15, 2018
- Product Code
- NKG
- Advisory Committee
- Orthopedic
- 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 |
|---|---|---|---|
| NKG | Posterior Cervical Screw System | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NKG), ordered by most recent decision date.
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Infinity OCT System
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CMORE® CT System; CMORE® CT System Navigated Instruments
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Infinity OCT System
FDA 510(k)
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ANAX OCT Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
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| 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 |