FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO SYNTHES MATRIX SYSTEM
K Number: K100952
·
Decision Aug 5, 2010
Classifications
1
FEI Numbers
407
Registration Numbers
407
Same Product Code
900
Applicant Total
36
Review Days
121
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Basic Information
- Device Name
- MODIFICATION TO SYNTHES MATRIX SYSTEM
- K Number
- K100952
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes Spine
- Date Received
- April 6, 2010
- Decision Date
- August 5, 2010
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
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Other Clearances by Synthes Spine
| K Number | Device Name | ||
|---|---|---|---|
| K122211 | SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS | Dec 17, 2012 | Substantially Equivalent |
| K120838 | SYNTHES MATRIX SYSTEM | Jul 31, 2012 | Substantially Equivalent |
| K111048 | SYNTHES SCOUT TACK FIXATION | Jun 14, 2012 | Unknown |
| K120928 | SYNTHES MATRIX SYSTEM | May 18, 2012 | Substantially Equivalent |
| K120571 | SYNTHES USS CONNECTOR | May 14, 2012 | Substantially Equivalent |
| K113149 | SYNTHES USS CONNECTORS | Feb 1, 2012 | Substantially Equivalent |
| K113044 | SYNTHES MIRS | Dec 21, 2011 | Substantially Equivalent |
| K111358 | SYNTHES USS | Nov 18, 2011 | Substantially Equivalent |
| K103558 | SYNTHES SCOUT VESSEL GUARD | Feb 18, 2011 | Unknown |
| K103287 | SYNTHES 6.0 COCR AND CPT TI-3 RODS | Jan 5, 2011 | Substantially Equivalent |