FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
N-FORCE FIXATION SYSTEM
K Number: K132244
·
Decision Mar 6, 2014
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
6
Review Days
231
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Basic Information
- Device Name
- N-FORCE FIXATION SYSTEM
- K Number
- K132244
- 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
- July 18, 2013
- Decision Date
- March 6, 2014
- 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 |
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Other Clearances by Innovision, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K151146 | N-Force Fixation System | Jul 24, 2015 | 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 |