FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARX SPINAL SYSTEM
K Number: K061600
·
Decision Aug 22, 2006
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
302
Applicant Total
36
Review Days
75
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Basic Information
- Device Name
- ARX SPINAL SYSTEM
- K Number
- K061600
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Life Spine
- Date Received
- June 8, 2006
- Decision Date
- August 22, 2006
- Product Code
- MNI
- 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 |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | FDA class 2 | Orthopedic |
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Other Clearances by Life Spine
| K Number | Device Name | ||
|---|---|---|---|
| K182470 | Plateau Spacer System | Nov 26, 2018 | Substantially Equivalent |
| K160169 | The Life Spine Subtalar Implant System | Jun 23, 2016 | Substantially Equivalent |
| K150368 | Tarsa-Link Wedge Fixation System | Mar 24, 2015 | Substantially Equivalent |
| K141905 | PRO-LINK WEDGE SYSTEM | Sep 26, 2014 | Substantially Equivalent |
| K133717 | LONGBOW SPACER SYSTEM | Sep 19, 2014 | Substantially Equivalent |
| K131077 | LIFE SPINE PLATEAU SPACER SYSTEM | Jul 17, 2013 | Substantially Equivalent |
| K123373 | NAUTILUS SPINAL SYSTEM | Mar 6, 2013 | Substantially Equivalent |
| K120998 | SOLSTICE CROSS CONNECTOR | Oct 1, 2012 | Substantially Equivalent |
| K111953 | NAUTILUS SPINAL SYSTEM | Aug 7, 2012 | Substantially Equivalent |
| K121116 | PLATEAU SPACER SYSTEM | May 8, 2012 | Substantially Equivalent |