Zyston Arc Interbody Spacer
FDA 510(k) K110650 · Biomet Spine (Aka Ebi, LLC)
510(k) numberK110650
Submission
- Device name
- Zyston Arc Interbody Spacer
- Applicant
- Biomet Spine (Aka Ebi, LLC)
Parsippany, NJ, US - Received
- March 4, 2011
- Decision date
- June 30, 2011
- 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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| 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 |
| K122989 | Biomet Lateral Spacer SystemMAX · Traditional | 10/24/2012SE |
| K122378 | Nextgen Altius Oct SystemKWP · Special | 09/20/2012SE |
| K113593 | Nextgen Altius Oct SystemKWP · Traditional | 04/17/2012SE |
Questions and answers
When was Zyston Arc Interbody Spacer cleared by the FDA?
Zyston Arc Interbody Spacer (K110650) received a 510(k) decision of Substantially Equivalent on June 30, 2011, 118 days after the submission was received.
What is the product code of K110650?
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.