FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM
K Number: K043077
·
Decision Dec 17, 2004
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
189
Applicant Total
44
Review Days
39
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Basic Information
- Device Name
- MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM
- K Number
- K043077
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tornier
- Date Received
- November 8, 2004
- Decision Date
- December 17, 2004
- Product Code
- KWS
- 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 |
|---|---|---|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | FDA class 2 | Orthopedic |
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Other Clearances by Tornier
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|---|---|---|---|
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| 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 |