FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTEOMED EXTREMIFUSE SYSTEM
K Number: K140283
·
Decision Feb 28, 2014
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
12
Review Days
24
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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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Other Clearances by Osteomed
| K Number | Device Name | ||
|---|---|---|---|
| K203479 | ExtremiLOCK Lateral Ankle Fusion Plates | Feb 24, 2021 | Substantially Equivalent |
| K162542 | OsteoMed PINNACLE Driver | May 19, 2017 | Substantially Equivalent |
| K162544 | OsteoMed PINNACLE Driver | Apr 4, 2017 | Substantially Equivalent |
| K161041 | OsteoMed ExtremiLOCK Wrist Plating System | May 19, 2016 | Substantially Equivalent |
| K152145 | OsteoMed ExtremiLOCK Wrist Plating System | Dec 21, 2015 | Substantially Equivalent |
| K151195 | OsteoMed IMF Screw | Sep 21, 2015 | Substantially Equivalent |
| K140978 | OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM | Dec 18, 2014 | Substantially Equivalent |
| 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 |