FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STAXX XD SYSTEM
K Number: K101288
·
Decision Sep 10, 2010
Classifications
1
FEI Numbers
215
Registration Numbers
215
Same Product Code
275
Applicant Total
40
Review Days
126
Basic Information
- Device Name
- STAXX XD SYSTEM
- K Number
- K101288
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SPINE WAVE, INC.
- Date Received
- May 7, 2010
- Decision Date
- September 10, 2010
- Product Code
- MQP
- 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 |
|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K153222 | Leva Spacer System | Apr 15, 2016 | Substantially Equivalent |
| K160003 | Sniper (R) Spine System | Feb 26, 2016 | Substantially Equivalent |
| K152620 | Spine Wave Gen II Expandable Interbody System | Jan 15, 2016 | Substantially Equivalent |
| K152174 | Sniper Spine System | Aug 31, 2015 | Substantially Equivalent |
| K151813 | Sniper Spine System | Jul 31, 2015 | Substantially Equivalent |
| K151581 | Leva Spacer System | Jul 9, 2015 | Substantially Equivalent |
| K150285 | Leva(TM) Spacer System | Mar 5, 2015 | Substantially Equivalent |
| K142996 | StaXx(R) XD System | Feb 19, 2015 | Substantially Equivalent |