FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
UNiD Spine Analyzer
K Number: K170172
·
Decision May 24, 2017
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
14
Review Days
125
Basic Information
- Device Name
- UNiD Spine Analyzer
- K Number
- K170172
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDICREA INTERNATIONAL
- Date Received
- January 19, 2017
- Decision Date
- May 24, 2017
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by MEDICREA INTERNATIONAL
| K Number | Device Name | ||
|---|---|---|---|
| K153169 | PASS OCT Patient Specific Rods | Jan 29, 2016 | Substantially Equivalent |
| K150049 | PASS LP Spinal System | Feb 10, 2015 | Substantially Equivalent |
| K140738 | PASS LP SPINAL SYSTEM | Nov 4, 2014 | Substantially Equivalent |
| K133906 | C-JAWS CERVICAL COMPRESSIVE STAPLE | Jul 24, 2014 | Substantially Equivalent |
| K132395 | LIGAPASS | Dec 6, 2013 | Substantially Equivalent |
| K132574 | PASS LP SPINAL SYSTEM | Nov 8, 2013 | Substantially Equivalent |
| K132575 | PASS LP SPINAL SYSTEM | Oct 3, 2013 | Substantially Equivalent |
| K121979 | PASS OCT SPINAL SYSTEM | Mar 21, 2013 | Substantially Equivalent |
| K123138 | PASS LP SPINAL SYSTEM | Feb 5, 2013 | Unknown |
| K121323 | MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE | Jul 18, 2012 | Substantially Equivalent |