FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
XIA 4.5 SPINAL SYSTEM
K Number: K121342
·
Decision Jun 22, 2012
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
124
Review Days
49
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Basic Information
- Device Name
- XIA 4.5 SPINAL SYSTEM
- K Number
- K121342
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Stryker Corp.
- Date Received
- May 4, 2012
- Decision Date
- June 22, 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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