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Mariner Cap System

by SeaSpine Orthopedics Corporation

510(k) K201240

Mariner Cap System is a Class II device made by SeaSpine Orthopedics Corporation, cleared under FDA 510(k) K201240 on 5 Aug 2020, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK201240 Date5 Aug 2020ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OWI
Device class
Class II
Regulation
21 CFR Part 888.3010
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K201240

7 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K201240
UDI-DISize and differences
Mariner Cap 369690
SeaSpine Orthopedics Corporation
369690 / 36969010889981220907
Single use: yes
On the market
Mariner Cap 569062
SeaSpine Orthopedics Corporation
569062 / 56906210889981220914
Single use: no
On the market
Mariner Cap 569063
SeaSpine Orthopedics Corporation
569063 / 56906310889981220921
Single use: no
On the market
Mariner Cap 569295
SeaSpine Orthopedics Corporation
569295 / 56929510889981220938
Single use: no
On the market
Mariner Cap 569326
SeaSpine Orthopedics Corporation
569326 / 56932610889981220945
Single use: no
On the market
Mariner Cap 902136
SeaSpine Orthopedics Corporation
902136 / 90213610889981239855
Single use: no
On the market
Mariner Cap 902137
SeaSpine Orthopedics Corporation
902137 / 90213710889981239862
Single use: no
On the market

Similar devices

Other devices filed under FDA product code OWI (Bone Fixation Cerclage, Sublaminar).

Other devices from SeaSpine Orthopedics Corporation

See all devices from SeaSpine Orthopedics Corporation →