FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AEQUALIS HUMERAL NAIL SYSTEM
K Number: K082754
·
Decision Jan 27, 2009
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
44
Review Days
130
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Basic Information
- Device Name
- AEQUALIS HUMERAL NAIL SYSTEM
- K Number
- K082754
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tornier
- Date Received
- September 19, 2008
- Decision Date
- January 27, 2009
- Product Code
- HSB
- 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 |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | FDA class 2 | Orthopedic |
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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 |
| K082120 | AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS | Oct 24, 2008 | Substantially Equivalent |
| K081059 | AEQUALIS REVERSED SHOULDER PROSTHESIS | Jul 17, 2008 | Substantially Equivalent |
| K071948 | AEQUALIS REVERSED ADAPTER | Oct 18, 2007 | Substantially Equivalent |