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Mariner Cap 569062

by SeaSpine Orthopedics Corporation

Mariner Cap 569062 is a Class II device made by SeaSpine Orthopedics Corporation, cleared under FDA 510(k) K201240 on 5 Aug 2020 and listed in FDA GUDID since 24 Nov 2020 (UDI-DI 10889981220914), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K201240

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10889981220914 UDI-DI Date24 Nov 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201240 Date5 Aug 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201240 decided 5 Aug 2020 Active
  • FDA GUDID UDI-DI 10889981220914 listed 24 Nov 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201240
  2. Listed FDA GUDID 10889981220914

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mariner Cap
Generic name
Internal spinal fixation system cable tensioner
Model / Ref / Catalog
569062
Primary DI / UDI-DI
10889981220914
510(k) Number
FDA product code
OWI
GMDN term
Internal spinal fixation system cable tensioner
Device class
Class II
Regulation number
888.3010
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Internal spinal fixation system cable tensioner

Cleared under the same submission (K201240)

and 2 more cleared under K201240

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 →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)