FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTREPID SPINAL SYSTEM
K Number: K091813
·
Decision Nov 17, 2009
Classifications
1
FEI Numbers
254
Registration Numbers
254
Same Product Code
194
Applicant Total
145
Review Days
152
Basic Information
- Device Name
- INTREPID SPINAL SYSTEM
- K Number
- K091813
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDTRONIC SOFAMOR DANEK
- Date Received
- June 18, 2009
- Decision Date
- November 17, 2009
- Product Code
- OVD
- 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K121982 | SOVEREIGN SPINAL SYSTEM | Jul 26, 2012 | Substantially Equivalent |
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| K113529 | CD HORIZON VOYAGER SPINAL SYSTEM | Feb 9, 2012 | Unknown |
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| K111457 | CD HORIZON SPINAL SYSTEM | Sep 15, 2011 | Unknown |
| K111525 | PERIMETER INTERBODY FUSION DEVICE | Aug 24, 2011 | Substantially Equivalent |
| K103731 | CAPSTONE R SPINAL SYSTEM | Jul 18, 2011 | Substantially Equivalent |
| K110676 | TSRH SPINAL SYSTEM | May 23, 2011 | Substantially Equivalent |