FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY
K Number: K131792
·
Decision Dec 16, 2013
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
42
Applicant Total
8
Review Days
181
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Basic Information
- Device Name
- SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY
- K Number
- K131792
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5910
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes, Inc.
- Date Received
- June 18, 2013
- Decision Date
- December 16, 2013
- Product Code
- GXQ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GXQ | Dura Substitute | FDA class 2 | Neurology |
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| 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 |