FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT
K Number: K130682
·
Decision Aug 13, 2013
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
79
Applicant Total
14
Review Days
153
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Basic Information
- Device Name
- MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT
- K Number
- K130682
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4880
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hager& Meisinger GmbH
- Date Received
- March 13, 2013
- Decision Date
- August 13, 2013
- 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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