CoreLink® M3 Stand-Alone Anterior Lumbar System
FDA 510(k) K180814 · Corelink, LLC
510(k) numberK180814
Submission
- Device name
- CoreLink® M3 Stand-Alone Anterior Lumbar System
- Applicant
- Corelink, LLC
St. Louis, MO, US - Received
- March 29, 2018
- Decision date
- August 10, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize lumbar 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 OVD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional | INNO Holdings Inc. DBA Innovasis | 09/11/2026SE |
| K261408 | SABER-XA SystemOVD · Traditional | Elevation Spine | 08/03/2026SE |
| K261809 | Interwedge® Standalone LateralOVD · Special | Foundation Surgical Group | 07/31/2026SE |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | Kyocera Medical Technologies, Inc. | 07/15/2026SE |
| K260810 | Anteralign LS coverplateOVD · Traditional | Tyber Medical, LLC | 06/10/2026SE |
| K254202 | MectaLIF 3D Metal AnteriorOVD · Traditional | Medacta International S.A. | 05/05/2026SE |
| K253401 | SCRIPT Implant SystemOVD · Traditional | Globus Medical, Inc. | 04/29/2026SE |
| K253559 | Ventana A Anterior Lumbar Interbody SystemOVD · Traditional | Spinal Elements, Inc. | 02/25/2026SE |
| K251829 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | Degen Medical | 12/08/2025SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | Alphatec Spine | 09/03/2025SE |
More from Alphatec Spine
| 510(k) | Device | Decision |
|---|---|---|
| K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…MAX · Traditional | 12/08/2023SE |
| K231494 | CoreLink Robotic Navigation InstrumentsOLO · Traditional | 10/27/2023SE |
| K232116 | CoreLink Navigation InstrumentsOLO · Special | 08/16/2023SE |
| K230329 | F3D Interbody SystemODP · Traditional | 06/06/2023SE |
| K230880 | CoreLink Navigation InstrumentsOLO · Special | 05/02/2023SE |
| K223708 | Entasis 3D Dual-Lead Sacroiliac Implant SystemOUR · Traditional | 03/21/2023SE |
| K221776 | NextGen Pedicle Screw SystemNKB · Traditional | 08/09/2022SE |
| K220973 | CoreLink Navigation InstrumentsOLO · Traditional | 06/01/2022SE |
| K211417 | F3D-C2 Cervical Stand-Alone SystemOVE · Traditional | 02/04/2022SE |
| K214059 | CoreLink Navigation InstrumentsOLO · Special | 01/19/2022SE |
Questions and answers
When was CoreLink® M3 Stand-Alone Anterior Lumbar System cleared by the FDA?
CoreLink® M3 Stand-Alone Anterior Lumbar System (K180814) received a 510(k) decision of Substantially Equivalent on August 10, 2018, 134 days after the submission was received.
What is the product code of K180814?
The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.