FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHECEL DURA REPLACEMENT DEVICES
K Number: K113071
·
Decision Jan 9, 2012
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
42
Applicant Total
11
Review Days
84
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Basic Information
- Device Name
- SYNTHECEL DURA REPLACEMENT DEVICES
- K Number
- K113071
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5910
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes
- Date Received
- October 17, 2011
- Decision Date
- January 9, 2012
- 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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| K Number | Device Name | ||
|---|---|---|---|
| K123723 | SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM | Sep 5, 2013 | Substantially Equivalent |
| K122455 | SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM | Apr 11, 2013 | Substantially Equivalent |
| K110604 | VBB SYSTEM | Dec 13, 2011 | Substantially Equivalent |
| K093772 | SYNTHES STERNAL FIXATION SYSTEM | Mar 29, 2010 | Substantially Equivalent |
| K013072 | CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP) | Nov 26, 2002 | Substantially Equivalent |
| K020602 | SYNTHES PILON PLATE | May 20, 2002 | Substantially Equivalent |
| K010108 | USS-LINE EXTENSION | Jun 6, 2001 | Substantially Equivalent |
| K003836 | SYNTHES SYNEX SPACER SYSTEM | May 29, 2001 | Substantially Equivalent |
| K003061 | SYNTHES USS (10.0MM SIDE OPENING SCREWS) | Oct 30, 2000 | Substantially Equivalent |
| K982732 | SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS) | Oct 8, 1998 | Substantially Equivalent |