FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
PALACOS LV+G
K Number: K050854
·
Decision Jul 7, 2005
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
71
Applicant Total
10
Review Days
94
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Basic Information
- Device Name
- PALACOS LV+G
- K Number
- K050854
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heraeus Kulzer,GmbH
- Date Received
- April 4, 2005
- Decision Date
- July 7, 2005
- 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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Other Clearances by Heraeus Kulzer,GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K083652 | IBOND TOTAL ETCH | Jan 21, 2009 | Substantially Equivalent |
| K080338 | CUTTERSIL ACTIVATOR UNIVERSAL PLUS | Apr 21, 2008 | Substantially Equivalent |
| K073554 | NEUN | Feb 4, 2008 | Substantially Equivalent |
| K062515 | RETENTION FLOW OPAQUE | Nov 22, 2006 | Substantially Equivalent |
| K050085 | OSTEOPAL V | Sep 14, 2005 | Substantially Equivalent |
| K050855 | PALAMED G | Jul 7, 2005 | Substantially Equivalent |
| K051006 | IBOND NEXT GENERATION | Jun 7, 2005 | Substantially Equivalent |
| K042199 | TRANSLUX POWER BLUE | Sep 8, 2004 | Substantially Equivalent |
| K034049 | HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM | Mar 1, 2004 | Substantially Equivalent |