FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
N-Force Fixation System
K Number: K151146
·
Decision Jul 24, 2015
Classifications
1
FEI Numbers
653
Registration Numbers
653
Same Product Code
1040
Applicant Total
6
Review Days
86
Basic Information
- Device Name
- N-Force Fixation System
- K Number
- K151146
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- INNOVISION, INC.
- Date Received
- April 29, 2015
- Decision Date
- July 24, 2015
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HWC), ordered by most recent decision date.
Eleganz Fusion Screw System (Fusion Screw System)
FDA 510(k)
FDA Class 2
·Orthopedic
TriMed® Compression Screws
FDA 510(k)
FDA Class 2
·Orthopedic
SnapHammer Hammertoe Correction System
FDA 510(k)
FDA Class 2
·Orthopedic
TITANEX Screw Systems
FDA 510(k)
FDA Class 2
·Orthopedic
Caliber Intramedullary Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by INNOVISION, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K132244 | N-FORCE FIXATION SYSTEM | Mar 6, 2014 | Substantially Equivalent |
| K102528 | N-FORCE FIXATION SYSTEM | Jul 28, 2011 | Substantially Equivalent |
| K011914 | HYDRO2, HS-75 | Jul 27, 2001 | Substantially Equivalent |
| K000485 | HYDRO2, HS-75 | May 12, 2000 | Substantially Equivalent |
| K944223 | ACCUCON | Dec 7, 1994 | Substantially Equivalent |