FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
TORNIER CEMENT RESTRICTOR
K Number: K061824
·
Decision Sep 14, 2006
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
36
Applicant Total
44
Review Days
78
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Basic Information
- Device Name
- TORNIER CEMENT RESTRICTOR
- K Number
- K061824
- 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
- Tornier
- Date Received
- June 28, 2006
- Decision Date
- September 14, 2006
- 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 |
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Other Clearances by Tornier
| K Number | Device Name | ||
|---|---|---|---|
| K112144 | AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS | Mar 13, 2012 | Substantially Equivalent |
| K111970 | KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT | Feb 23, 2012 | Substantially Equivalent |
| K111902 | AEQUALIS SHOULDER SYSTEM | Nov 3, 2011 | Substantially Equivalent |
| K094013 | HLS KNEETEC SYSTEM | May 5, 2011 | Substantially Equivalent |
| K100142 | AEQUALIS REVERSED SHOULDER PROSTHESIS | May 6, 2010 | Substantially Equivalent |
| K091870 | TORNIER, PITON FIXATION IMPLANT SYSTEM | Sep 21, 2009 | Substantially Equivalent |
| K090076 | SALTO TALARIS TOTAL ANKLE PROSTHESIS | Mar 17, 2009 | Substantially Equivalent |
| K082754 | AEQUALIS HUMERAL NAIL SYSTEM | Jan 27, 2009 | Substantially Equivalent |
| K082120 | AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS | Oct 24, 2008 | Substantially Equivalent |
| K081059 | AEQUALIS REVERSED SHOULDER PROSTHESIS | Jul 17, 2008 | Substantially Equivalent |