FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Omega LIF System
K Number: K150395
·
Decision Aug 10, 2015
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
16
Review Days
173
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Basic Information
- Device Name
- Omega LIF System
- K Number
- K150395
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Amendia, Inc.
- Date Received
- February 18, 2015
- Decision Date
- August 10, 2015
- 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 Amendia, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K160924 | Amendia Interbody Fusion Devices | Nov 8, 2016 | Substantially Equivalent |
| K161842 | Overwatch Spine System | Oct 13, 2016 | Substantially Equivalent |
| K152920 | Savannah-T® Pedicle Screw System | Jul 8, 2016 | Substantially Equivalent |
| K153152 | Syzygy Stabilization System | Apr 27, 2016 | Substantially Equivalent |
| K160291 | Optimus ALIF System | Feb 18, 2016 | Substantially Equivalent |
| K152972 | Amendia Stand-Alone Cervical System | Jan 14, 2016 | Substantially Equivalent |
| K151310 | Amendia Interbody Fusion Devices | Jan 6, 2016 | Substantially Equivalent |
| K152460 | Rectangular Corpectomy Cage | Dec 22, 2015 | Substantially Equivalent |
| K152455 | Amendia Cervical Plate System | Oct 15, 2015 | Substantially Equivalent |
| K151322 | Amendia Interbody Fusion Devices | Sep 10, 2015 | Substantially Equivalent |