Alta ACDF System
FDA 510(k) K152622 · Biomet Spine
510(k) numberK152622
Submission
- Device name
- Alta ACDF System
- Applicant
- Biomet Spine
Broomfield, CO, US - Received
- September 14, 2015
- Decision date
- July 8, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVE – Intervertebral Fusion Device With Integrated Fixation, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Other 510(k)s with product code OVE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261882 | Pisces-SC Standalone Cervical Interbody SystemOVE · Traditional | Osseus Fusions Systems, LLC | 08/21/2026SE |
| K261451 | ZSAlign Cervical Interbody SystemOVE · Traditional | ZSFab, Inc. | 07/31/2026SE |
| K262094 | E3D-C Interbody SystemOVE · Special | Evolution Spine | 07/22/2026SE |
| K261279 | DeltaNEC Interbody SystemOVE · Traditional | Nexus Spine | 06/22/2026SE |
| K252982 | CONDUIT ZERO-P VA Secured Spacer SystemOVE · Traditional | Avalign Technologies, Inc. | 06/18/2026SE |
| K260036 | NeckTune 3D SA Cervical CageOVE · Traditional | Medyssey Co, Ltd. | 06/15/2026SE |
| K260660 | SABER-C SystemOVE · Traditional | Elevation Spine | 04/27/2026SE |
| K253213 | SAGI Cervical Cage SystemOVE · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 04/20/2026SE |
| K252774 | Uni-C Cervical Cage SystemOVE · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 04/15/2026SE |
| K260038 | E3D-C Interbody SystemOVE · Special | Evolution Spine | 02/04/2026SE |
More from Evolution Spine
| 510(k) | Device | Decision |
|---|---|---|
| K153695 | Biomet Spine Fusion SystemMAX · Special | 01/21/2016SE |
| K151974 | Polaris Spinal SystemNKB · Traditional | 11/13/2015SE |
| 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 |
| K112014 | Zyston Straight Spacer SystemMAX · Traditional | 10/17/2011SE |
Questions and answers
When was Alta ACDF System cleared by the FDA?
Alta ACDF System (K152622) received a 510(k) decision of Substantially Equivalent on July 8, 2016, 298 days after the submission was received.
What is the product code of K152622?
The FDA product code is OVE – Intervertebral Fusion Device With Integrated Fixation, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.