Zyston Straight Spacer System
FDA 510(k) K112014 · Biomet Spine
510(k) numberK112014
Submission
- Device name
- Zyston Straight Spacer System
- Applicant
- Biomet Spine
Parsippany, NJ, US - Received
- July 14, 2011
- Decision date
- October 17, 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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More from Life Spine, Inc.
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|---|---|---|
| K152622 | Alta ACDF SystemOVE · Traditional | 07/08/2016SE |
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| K151064 | Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…OVE · Traditional | 08/12/2015SE |
| K151483 | Biomet Spine Fusion SystemMAX · Traditional | 07/31/2015SE |
| K151224 | Lineum OCT Spine SystemNKG · Traditional | 06/30/2015SE |
| K142634 | Biomet Spine Fusion SystemMAX · Traditional | 03/12/2015SE |
| K141791 | Biomet Fusion SystemOVD · Traditional | 10/09/2014SE |
| K141804 | Polaris Spinal System - Ha CoatedNKB · Traditional | 09/25/2014SE |
| K121130 | Polaris Spinal System-Ballista Spinal RodsNKB · Special | 06/15/2012SE |
Questions and answers
When was Zyston Straight Spacer System cleared by the FDA?
Zyston Straight Spacer System (K112014) received a 510(k) decision of Substantially Equivalent on October 17, 2011, 95 days after the submission was received.
What is the product code of K112014?
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.