FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MESA SPINAL SYSTEM
K Number: K052398
·
Decision Dec 7, 2005
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
302
Applicant Total
8
Review Days
98
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Basic Information
- Device Name
- MESA SPINAL SYSTEM
- K Number
- K052398
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- K2m, LLC
- Date Received
- August 31, 2005
- Decision Date
- December 7, 2005
- Product Code
- MNI
- 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 |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | FDA class 2 | Orthopedic |
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| K140529 | EVEREST SPINAL SYSTEM | May 22, 2014 | Substantially Equivalent |
| K052404 | DENALI DEFORMITY SYSTEM | May 23, 2006 | Substantially Equivalent |
| K060442 | PYRENEES CERVICAL PLATE SYSTEM | May 15, 2006 | Substantially Equivalent |
| K051531 | TECTONIC CERVICAL PLATE SYSTEM | Oct 17, 2005 | Substantially Equivalent |
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