FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZAVATION SPINAL SYSTEM
K Number: K112484
·
Decision Nov 22, 2011
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
302
Applicant Total
15
Review Days
85
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Basic Information
- Device Name
- ZAVATION SPINAL SYSTEM
- K Number
- K112484
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zavation, LLC
- Date Received
- August 29, 2011
- Decision Date
- November 22, 2011
- 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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Other Clearances by Zavation, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K162206 | Zavation IBF | Apr 4, 2017 | Substantially Equivalent |
| K162575 | Z-LINKPC System | Mar 3, 2017 | Substantially Equivalent |
| K162824 | Z-Span Plate System | Feb 17, 2017 | Substantially Equivalent |
| K161016 | Z-Clamp ISP System | Oct 19, 2016 | Substantially Equivalent |
| K153404 | Zavation Spinal System | Apr 21, 2016 | Substantially Equivalent |
| K160362 | Z-Span Plate System | Mar 22, 2016 | Substantially Equivalent |
| K142392 | Zavation Posterior LEIF | Apr 29, 2015 | Substantially Equivalent |
| K142271 | Zavation Z-Link Lumbar | Dec 19, 2014 | Substantially Equivalent |
| K141419 | ZVPLASTY | Sep 12, 2014 | Substantially Equivalent |
| K141005 | Z-LINK CERVICAL | Aug 7, 2014 | Substantially Equivalent |