FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
K Number: K123723
·
Decision Sep 5, 2013
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
41
Applicant Total
11
Review Days
275
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Basic Information
- Device Name
- SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM
- K Number
- K123723
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes
- Date Received
- December 4, 2012
- Decision Date
- September 5, 2013
- Product Code
- GWO
- 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 |
|---|---|---|---|
| GWO | Plate, Cranioplasty, Preformed, Alterable | FDA class 2 | Neurology |
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Other Clearances by Synthes
| K Number | Device Name | ||
|---|---|---|---|
| K122455 | SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM | Apr 11, 2013 | Substantially Equivalent |
| K113071 | SYNTHECEL DURA REPLACEMENT DEVICES | Jan 9, 2012 | 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 |