FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
INTEGRA FACET FIXATION SYSTEM
K Number: K132859
·
Decision Nov 18, 2013
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
70
Applicant Total
25
Review Days
67
Basic Information
- Device Name
- INTEGRA FACET FIXATION SYSTEM
- K Number
- K132859
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SEASPINE, INC.
- Date Received
- September 12, 2013
- Decision Date
- November 18, 2013
- Product Code
- MRW
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MRW | System, Facet Screw Spinal Device | FDA unclassified | Unknown |
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Other Clearances by SEASPINE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K150469 | Integra Laminoplasty System | Mar 23, 2015 | Substantially Equivalent |
| K133418 | INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM | May 1, 2014 | Substantially Equivalent |
| K121924 | INTEGRA INTERSPINOUS PROCESS SYSTEM | Sep 4, 2013 | Substantially Equivalent |
| K130830 | INTEGRA LAMINOPLASTY SYSTEM | May 9, 2013 | Substantially Equivalent |
| K122571 | MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM | Dec 12, 2012 | Substantially Equivalent |
| K112206 | CARDIFF ANTERIOR CERVICAL PLATE SYSTEM | Jan 25, 2012 | Substantially Equivalent |
| K111671 | SEASPINE MONOPOLAR PROBE SYSYEM | Dec 28, 2011 | Substantially Equivalent |
| K102026 | SEASPINE SPACER SYSTEM | May 12, 2011 | Substantially Equivalent |
| K103297 | REDONDO-L | Jan 27, 2011 | Substantially Equivalent |
| K092521 | ZUMA-C | Apr 13, 2010 | Substantially Equivalent |