FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FixxSure® X-Link
K Number: K162143
·
Decision Sep 23, 2016
Classifications
1
FEI Numbers
338
Registration Numbers
338
Same Product Code
308
Applicant Total
15
Review Days
53
Basic Information
- Device Name
- FixxSure® X-Link
- K Number
- K162143
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- INNOVASIS, INC.
- Date Received
- August 1, 2016
- Decision Date
- September 23, 2016
- Product Code
- MNH
- 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 |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K150500 | Px PEEK IBF System | Jun 19, 2015 | Substantially Equivalent |
| K141644 | INNOVASIS CRANIAL SYSTEM | Nov 7, 2014 | Substantially Equivalent |
| K132765 | PFX SPINOUS PROCESS FIXATION SYSTEM | Jul 14, 2014 | Substantially Equivalent |
| K140238 | EXCELLA III-D SPINAL DEFORMITY SYSTEM | May 7, 2014 | Substantially Equivalent |
| K132991 | C-BOX PEEK CERVICAL IBF | Feb 12, 2014 | Substantially Equivalent |
| K121581 | BOX PEEK VBR SYSTEM, | Oct 17, 2012 | Substantially Equivalent |
| K102248 | EXCELLA II SPINAL SYSTEM MODEL EC2-00 | Oct 7, 2010 | Substantially Equivalent |
| K071921 | INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS) | Nov 16, 2007 | Substantially Equivalent |