FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OsteoMed IMF Screw
K Number: K151195
·
Decision Sep 21, 2015
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
79
Applicant Total
12
Review Days
140
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Basic Information
- Device Name
- OsteoMed IMF Screw
- K Number
- K151195
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4880
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteomed
- Date Received
- May 4, 2015
- Decision Date
- September 21, 2015
- Product Code
- DZL
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| DZL | Screw, Fixation, Intraosseous | FDA class 2 | Dental |
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| K140978 | OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM | Dec 18, 2014 | Substantially Equivalent |
| K140283 | OSTEOMED EXTREMIFUSE SYSTEM | Feb 28, 2014 | Substantially Equivalent |
| K131851 | OSTEOMED NEURO RONGEUR | Dec 6, 2013 | Substantially Equivalent |
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