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510(k) K241466

Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System by SeaSpine Orthopedics Corporation — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2024
Date Received
May 23, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by SeaSpine Orthopedics Corporation

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  • K243659 — FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments (April 2, 2025)
  • K242273 — Cove Putty, OsteoCove Putty (September 25, 2024)
  • K240566 — Reef L Interbody System; WaveForm L Interbody System (April 26, 2024)
  • K232566 — NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System (April 19, 2024)
  • K233694 — Meridian Interbody System; WaveForm A Interbody System (January 12, 2024)
  • K233414 — Shoreline ACS Interbody System; Shoreline RT Interbody System (November 28, 2023)
  • K232668 — Cove Strip, OsteoCove Strip (September 27, 2023)
  • K231030 — Cove Putty, OsteoCove Putty (September 14, 2023)
  • K230486 — Cove Strip (August 21, 2023)

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  • K252610 — ZSFab Lumbar Interbody System (November 25, 2025)
  • K252351 — UniSpace® TPLIF Cage (October 28, 2025)
  • K253377 — Expandable Titanium PLIF/TLIF System (October 24, 2025)
  • K251479 — Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion C (September 18, 2025)