FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
ANAX OCT Spinal System
K Number: K183383
·
Decision Dec 12, 2018
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
117
Applicant Total
23
Review Days
6
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Basic Information
- Device Name
- ANAX OCT Spinal System
- K Number
- K183383
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3075
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- U&I Corporation
- Date Received
- December 6, 2018
- Decision Date
- December 12, 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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CMORE® CT System; CMORE® CT System Navigated Instruments
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Infinity OCT System
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ANAX OCT Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
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