FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Saxxony Posterior Cervical Thoracic System
K Number: K182508
·
Decision Nov 13, 2018
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
117
Applicant Total
22
Review Days
62
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Basic Information
- Device Name
- Saxxony Posterior Cervical Thoracic System
- K Number
- K182508
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3075
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nexxt Spine, LLC
- Date Received
- September 12, 2018
- Decision Date
- November 13, 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 |
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