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510(k) K240566

Reef L Interbody System; WaveForm L Interbody System by SeaSpine Orthopedics Corporation — Product Code MAX

K240566 is an FDA 510(k) premarket notification submitted by SeaSpine Orthopedics Corporation for the device "Reef L Interbody System; WaveForm L Interbody System". The FDA issued a decision of Substantially Equivalent on April 26, 2024. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. SeaSpine Orthopedics Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2024
Date Received
February 29, 2024
Clearance Type
Traditional
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

  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space (July 1, 2026)
  • K250908 — Virata Spinal Fixation System (June 18, 2025)
  • K243659 — FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments (April 2, 2025)
  • K242273 — Cove Putty, OsteoCove Putty (September 25, 2024)
  • K241466 — Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral S (June 20, 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)

Other clearances for product code MAX

  • K253011 — Catalyft PL Expandable Interbody System (July 17, 2026)
  • K261020 — Symmetrix™ L Spinal System (July 14, 2026)
  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space (July 1, 2026)
  • K253151 — Fule Interbody Fusion Cage System (June 15, 2026)
  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K253894 — BMD Titanium Spinal Fusion System (May 28, 2026)
  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
  • K260837 — VersaLift Expandable System (May 12, 2026)
  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
  • K261067 — BEE PLIF Cage (April 30, 2026)

FDA data resources