FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
coflex-IF
K Number: K153302
·
Decision Sep 8, 2016
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
47
Applicant Total
11
Review Days
300
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- coflex-IF
- K Number
- K153302
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Paradigm Spine, LLC
- Date Received
- November 13, 2015
- Decision Date
- September 8, 2016
- Product Code
- PEK
- 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 |
|---|---|---|---|
| PEK | Spinous Process Plate | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PEK), ordered by most recent decision date.
Minuteman® G6 MIS Fusion Plate
FDA 510(k)
FDA Class 2
·Orthopedic
Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3
FDA 510(k)
FDA Class 2
·Orthopedic
Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate
FDA 510(k)
FDA Class 2
·Orthopedic
KeyLift Expandable Interlaminar Stabilization System
FDA 510(k)
FDA Class 2
·Orthopedic
primaLOK SP Interspinous Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Huvex Interspinous Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Paradigm Spine, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K120491 | DSS STABILIZATION SYSTEM-RIGID | May 9, 2012 | Unknown |
| K112595 | COFLEX-F | Feb 13, 2012 | Substantially Equivalent |
| K113625 | DSS STABILIZATION SYSTEM | Jan 10, 2012 | Unknown |
| K093438 | PARADIGM INTERSPINOUS FUSION PLATE | Oct 6, 2010 | Substantially Equivalent |
| K101083 | DSS STABILIZATION SYSTEM | Jul 2, 2010 | Unknown |
| K091944 | MODIFICATION TO: DSS STABILIZATION SYSTEM | Aug 3, 2009 | Substantially Equivalent |
| K090099 | DSS STABILIZATION SYSTEM | Jun 19, 2009 | Unknown |
| K090408 | MODIFICATION TO: DSS STABILIZATION SYSTEM | Mar 20, 2009 | Unknown |
| K080241 | DDS STABILIZATION SYSTEM | Nov 28, 2008 | Unknown |
| K072969 | DSS | Jan 24, 2008 | Unknown |