FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
S4C NAVIGATION INSTRUMENTS
K Number: K130887
·
Decision Aug 13, 2013
Classifications
1
FEI Numbers
370
Registration Numbers
370
Same Product Code
404
Applicant Total
18
Review Days
137
Basic Information
- Device Name
- S4C NAVIGATION INSTRUMENTS
- K Number
- K130887
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AESCULAP IMPLANT SYSTEM, INC.
- Date Received
- March 29, 2013
- Decision Date
- August 13, 2013
- Product Code
- OLO
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
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|---|---|---|---|
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| K122985 | COLUMBUS REVISION KNEE SYSTEM | Oct 26, 2012 | Substantially Equivalent |
| K112551 | S4 SPINAL SYSTEM | Nov 21, 2011 | Substantially Equivalent |
| K101281 | VEGA KNEE SYSTEM | Jul 30, 2010 | Substantially Equivalent |
| K100147 | S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM | Jul 23, 2010 | Substantially Equivalent |