FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
K Number: K121574
·
Decision Jun 29, 2012
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
8
Review Days
30
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Basic Information
- Device Name
- SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
- K Number
- K121574
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes, Inc.
- Date Received
- May 30, 2012
- Decision Date
- June 29, 2012
- Product Code
- JEY
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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Other Clearances by Synthes, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K131792 | SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY | Dec 16, 2013 | Substantially Equivalent |
| K122647 | SYNTHES PATIENT SPECIFIC PLATE | Feb 28, 2013 | Substantially Equivalent |
| K113567 | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM | Nov 19, 2012 | Substantially Equivalent |
| K121502 | SYNTHES CURVILINEAR DISTRACTION SYSTEM | Aug 23, 2012 | Substantially Equivalent |
| K113251 | SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES | Dec 21, 2011 | Substantially Equivalent |
| K111323 | SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS | Nov 16, 2011 | Substantially Equivalent |
| K112689 | SYNTHES STERNAL FIXATION SYSTEM | Oct 26, 2011 | Substantially Equivalent |