FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTEOMED EXTREMIFUSE SYSTEM
K Number: K140283
·
Decision Feb 28, 2014
Classifications
1
FEI Numbers
653
Registration Numbers
653
Same Product Code
1040
Applicant Total
11
Review Days
24
Basic Information
- Device Name
- OSTEOMED EXTREMIFUSE SYSTEM
- K Number
- K140283
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OSTEOMED
- Date Received
- February 4, 2014
- Decision Date
- February 28, 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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|---|---|---|---|
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| K131851 | OSTEOMED NEURO RONGEUR | Dec 6, 2013 | Substantially Equivalent |
| K133437 | 1ST MTP PLATE | Dec 2, 2013 | Substantially Equivalent |
| K130412 | OSTEOMED EXTREMIFUSE SYSTEM | May 31, 2013 | Substantially Equivalent |
| K121304 | OSTEOMED CRANIAL DISTRACTION SYSTEM | Aug 22, 2012 | Substantially Equivalent |