Biomet Lateral Spacer System
FDA 510(k) K122989 · Biomet Spine (Aka Ebi, LLC)
510(k) numberK122989
Submission
- Device name
- Biomet Lateral Spacer System
- Applicant
- Biomet Spine (Aka Ebi, LLC)
Parsippany, NJ, US - Received
- September 26, 2012
- Decision date
- October 24, 2012
- 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 |
|---|---|---|
| K133518 | Maxan Anterior Cervical Plate SystemKWQ · Traditional | 11/05/2014SE |
| K140710 | Biomet Graft Delivery SyringesFMF · Traditional | 09/04/2014SE |
| K132373 | Biomet Access SystemPDQ · Traditional | 03/27/2014SE |
| K133746 | Polaris Spinal SystemNKB · Traditional | 03/12/2014SE |
| K131615 | Polaris Spinal SystemOSH · Traditional | 09/04/2013SE |
| K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemNKB · Traditional | 02/25/2013SE |
| K123451 | Polaris Spinal System - Ballista II RodsNKB · Special | 12/03/2012SE |
| K122378 | Nextgen Altius Oct SystemKWP · Special | 09/20/2012SE |
| K113593 | Nextgen Altius Oct SystemKWP · Traditional | 04/17/2012SE |
| K110650 | Zyston Arc Interbody SpacerMAX · Traditional | 06/30/2011SE |
Questions and answers
When was Biomet Lateral Spacer System cleared by the FDA?
Biomet Lateral Spacer System (K122989) received a 510(k) decision of Substantially Equivalent on October 24, 2012, 28 days after the submission was received.
What is the product code of K122989?
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.