FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALAMO T
K Number: K120401
·
Decision Oct 5, 2012
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
10
Review Days
240
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Basic Information
- Device Name
- ALAMO T
- K Number
- K120401
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alliance Partners, LLC
- Date Received
- February 8, 2012
- Decision Date
- October 5, 2012
- Product Code
- MAX
- 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
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Other Clearances by Alliance Partners, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K201521 | Medina Anterior Cervical Plate System | Aug 6, 2020 | Substantially Equivalent |
| K173128 | Alamo® C | Mar 22, 2018 | Substantially Equivalent |
| K141123 | ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM | Feb 27, 2015 | Substantially Equivalent |
| K141993 | NAKOMA ACP | Nov 6, 2014 | Substantially Equivalent |
| K140303 | ALAMO T | Apr 21, 2014 | Substantially Equivalent |
| K133321 | ALAMO C | Jan 9, 2014 | Substantially Equivalent |
| K122047 | ALAMO P | Sep 4, 2012 | Substantially Equivalent |
| K121181 | SWANNSHIDI BONE MARROW ASPIRATION NEEDLE | Aug 22, 2012 | Substantially Equivalent |
| K112361 | ALAMO C | Nov 30, 2011 | Substantially Equivalent |