NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
FDA 510(k) K203129 · Precision Spine, Inc.
510(k) numberK203129
Submission
- Device name
- NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
- Applicant
- Precision Spine, Inc.
Pear, MS, US - Received
- October 19, 2020
- Decision date
- January 12, 2021
- 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.
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| K260660 | SABER-C SystemOVE · Traditional | Elevation Spine | 04/27/2026SE |
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| K260038 | E3D-C Interbody SystemOVE · Special | Evolution Spine | 02/04/2026SE |
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Questions and answers
When was NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System cleared by the FDA?
NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System (K203129) received a 510(k) decision of Substantially Equivalent on January 12, 2021, 85 days after the submission was received.
What is the product code of K203129?
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.