FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
PALACOS R+G PRO
K Number: K142157
·
Decision Sep 5, 2014
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
70
Applicant Total
3
Review Days
30
Basic Information
- Device Name
- PALACOS R+G PRO
- K Number
- K142157
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HERAEUS MEDICAL GMBH
- Date Received
- August 6, 2014
- Decision Date
- September 5, 2014
- Product Code
- LOD
- 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 |
|---|---|---|---|
| LOD | Bone Cement | FDA class 2 | Orthopedic |
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