FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IN:C2 SPINAL FIXATION SYSTME
K Number: K141537
·
Decision Nov 25, 2014
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
161
Applicant Total
3
Review Days
168
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Basic Information
- Device Name
- IN:C2 SPINAL FIXATION SYSTME
- K Number
- K141537
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spine Smith Holdings, LLC
- Date Received
- June 10, 2014
- Decision Date
- November 25, 2014
- Product Code
- OVE
- 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 |
|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | FDA class 2 | Orthopedic |
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