Shoreline ACS Interbody System; Shoreline RT Interbody System
FDA 510(k) K233414 · SeaSpine Orthopedics Corporation
510(k) numberK233414
Submission
- Device name
- Shoreline ACS Interbody System; Shoreline RT Interbody System
- Applicant
- SeaSpine Orthopedics Corporation
Carlsbad, CA, US - Received
- October 10, 2023
- Decision date
- November 28, 2023
- 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 |
|---|---|---|
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | 07/01/2026SE |
| K250908 | Virata Spinal Fixation SystemNKB · Traditional | 06/18/2025SE |
| K243659 | FLASH Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsOLO · Traditional | 04/02/2025SE |
| K242273 | Cove Putty, OsteoCove PuttyMQV · Traditional | 09/25/2024SE |
| K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…MAX · Special | 06/20/2024SE |
| K240566 | Reef L Interbody System; WaveForm L Interbody SystemMAX · Traditional | 04/26/2024SE |
| K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…NKB · Traditional | 04/19/2024SE |
| K233694 | Meridian Interbody System; WaveForm A Interbody SystemMAX · Traditional | 01/12/2024SE |
| K232668 | Cove Strip, OsteoCove StripMQV · Special | 09/27/2023SE |
| K231030 | Cove Putty, OsteoCove PuttyMQV · Traditional | 09/14/2023SE |
Questions and answers
When was Shoreline ACS Interbody System; Shoreline RT Interbody System cleared by the FDA?
Shoreline ACS Interbody System; Shoreline RT Interbody System (K233414) received a 510(k) decision of Substantially Equivalent on November 28, 2023, 49 days after the submission was received.
What is the product code of K233414?
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.