Amendia Stand-Alone Cervical System
FDA 510(k) K152972 · Amendia, Inc.
510(k) numberK152972
Submission
- Device name
- Amendia Stand-Alone Cervical System
- Applicant
- Amendia, Inc.
Marietta, GA, US - Received
- October 8, 2015
- Decision date
- January 14, 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 |
|---|---|---|
| K160924 | Amendia Interbody Fusion DevicesMAX · Traditional | 11/08/2016SE |
| K161842 | Overwatch Spine SystemNKB · Traditional | 10/13/2016SE |
| 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 |
| 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 |
| K150395 | Omega LIF SystemMAX · Traditional | 08/10/2015SE |
Questions and answers
When was Amendia Stand-Alone Cervical System cleared by the FDA?
Amendia Stand-Alone Cervical System (K152972) received a 510(k) decision of Substantially Equivalent on January 14, 2016, 98 days after the submission was received.
What is the product code of K152972?
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.