Omega LIF System
FDA 510(k) K150395 · Amendia, Inc.
510(k) numberK150395
Submission
- Device name
- Omega LIF System
- Applicant
- Amendia, Inc.
Marietta, GA, US - Received
- February 18, 2015
- Decision date
- August 10, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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More from Life Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K160924 | Amendia Interbody Fusion DevicesMAX · Traditional | 11/08/2016SE |
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| K152920 | Savannah-T® Pedicle Screw SystemNKB · Traditional | 07/08/2016SE |
| K153152 | Syzygy Stabilization SystemNKB · Traditional | 04/27/2016SE |
| K160291 | Optimus ALIF SystemOVD · Special | 02/18/2016SE |
| K152972 | Amendia Stand-Alone Cervical SystemOVE · Traditional | 01/14/2016SE |
| K151310 | Amendia Interbody Fusion DevicesMAX · Traditional | 01/06/2016SE |
| K152460 | Rectangular Corpectomy CageMQP · Traditional | 12/22/2015SE |
| K152455 | Amendia Cervical Plate SystemKWQ · Traditional | 10/15/2015SE |
| K151322 | Amendia Interbody Fusion DevicesMAX · Traditional | 09/10/2015SE |
Questions and answers
When was Omega LIF System cleared by the FDA?
Omega LIF System (K150395) received a 510(k) decision of Substantially Equivalent on August 10, 2015, 173 days after the submission was received.
What is the product code of K150395?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.