FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS
K Number: K121130
·
Decision Jun 15, 2012
Classifications
1
FEI Numbers
413
Registration Numbers
413
Same Product Code
873
Applicant Total
19
Review Days
63
Basic Information
- Device Name
- POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS
- K Number
- K121130
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIOMET SPINE
- Date Received
- April 13, 2012
- Decision Date
- June 15, 2012
- 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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