FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES
K Number: K093046
·
Decision Mar 22, 2011
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
16
Applicant Total
10
Review Days
538
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Basic Information
- Device Name
- ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES
- K Number
- K093046
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synvasive Technology, Inc.
- Date Received
- September 30, 2009
- Decision Date
- March 22, 2011
- Product Code
- ONN
- 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 |
|---|---|---|---|
| ONN | Intraoperative Orthopedic Joint Assessment Aid | FDA class 2 | Neurology |
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