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510(k) K201240

Mariner Cap System by SeaSpine Orthopedics Corporation — Product Code OWI

K201240 is an FDA 510(k) premarket notification submitted by SeaSpine Orthopedics Corporation for the device "Mariner Cap System". The FDA issued a decision of Substantially Equivalent on August 5, 2020. The device falls under product code OWI (Bone Fixation Cerclage, Sublaminar), a Class II device regulated under 21 CFR 888.3010. SeaSpine Orthopedics Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2020
Date Received
May 8, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Fixation Cerclage, Sublaminar
Device Class
Class II
Regulation Number
888.3010
Review Panel
OR
Submission Type

Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.

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)
  • 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)

Other clearances for product code OWI

  • K261374 — LigaPASS™ System (May 27, 2026)
  • K253615 — Invictus Bands System (March 25, 2026)
  • K222097 — OLYMPIC Deformity Band System (May 4, 2023)
  • K230565 — HILINE™ Fixation System (April 20, 2023)
  • K213659 — LigaPASS™ 2.0 Ligament Augmentation System (May 24, 2022)
  • K211057 — LigaPASS® Spinal System, CD Horizon™ Spinal System (May 27, 2021)
  • K200281 — The Gecko Spinal System (March 31, 2020)
  • K200097 — Response BandLoc Spinal Fixation (March 16, 2020)
  • K191217 — JAZZ PF (August 2, 2019)
  • K190289 — Karma® Fixation System (April 3, 2019)

FDA data resources