FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KYPHON INFLATION SYRINGE
K Number: K103231
·
Decision Jan 24, 2011
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
2
Review Days
84
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Basic Information
- Device Name
- KYPHON INFLATION SYRINGE
- K Number
- K103231
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Spine, LLC
- Date Received
- November 1, 2010
- Decision Date
- January 24, 2011
- Product Code
- HRX
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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Other Clearances by Medtronic Spine, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K101765 | KYPHON ANCHOR FACET SCREW SYSTEM | Oct 22, 2010 | Substantially Equivalent |