FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS
K Number: K122211
·
Decision Dec 17, 2012
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
36
Review Days
145
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Basic Information
- Device Name
- SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS
- K Number
- K122211
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes Spine
- Date Received
- July 25, 2012
- Decision Date
- December 17, 2012
- Product Code
- HAW
- 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
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Other Clearances by Synthes Spine
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K093762 | SYNTHES ZERO-P | Dec 20, 2010 | Substantially Equivalent |