FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CEMSTOP CEMENT RESTRICTOR
K Number: K032685
·
Decision Nov 26, 2003
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
36
Applicant Total
11
Review Days
89
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Basic Information
- Device Name
- CEMSTOP CEMENT RESTRICTOR
- K Number
- K032685
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Teknimed, S.A.
- Date Received
- August 29, 2003
- Decision Date
- November 26, 2003
- Product Code
- LZN
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| LZN | Cement Obturator | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
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FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Teknimed, S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K103433 | F20 | Jan 3, 2011 | Substantially Equivalent |
| K090435 | VERTECEM | Dec 21, 2009 | Substantially Equivalent |
| K083005 | NANGEL | Mar 4, 2009 | Substantially Equivalent |
| K080873 | OPACITY + BONE CEMENT | Aug 28, 2008 | Substantially Equivalent |
| K062102 | ODONCER | Apr 16, 2007 | Substantially Equivalent |
| K043593 | SPINE-FIX BIOMIMETIC BONE CEMENT | Mar 17, 2006 | Substantially Equivalent |
| K042911 | CEMENTEK LV | Dec 27, 2004 | Substantially Equivalent |
| K041493 | CEMENTEK | Aug 19, 2004 | Substantially Equivalent |
| K040669 | CERAFORM BONE VOID FILLER | May 3, 2004 | Substantially Equivalent |
| K031826 | TRIHA + | Nov 28, 2003 | Substantially Equivalent |