FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO NAUTILUS SPINAL SYSTEM
K Number: K133564
·
Decision Feb 19, 2014
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
2
Review Days
91
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Basic Information
- Device Name
- MODIFICATION TO NAUTILUS SPINAL SYSTEM
- K Number
- K133564
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Life Spine, LLC
- Date Received
- November 20, 2013
- Decision Date
- February 19, 2014
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
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Other Clearances by Life Spine, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K040844 | LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM | Jul 23, 2004 | Substantially Equivalent |