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Mariner 41-8010

by SeaSpine Orthopedics Corporation

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K173882

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10889981160029 UDI-DI Date3 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173882 Date6 Feb 2018DecidedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2762-2026 FDA Class II initiated 28 May 2026

    Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mariner
Generic name
Bone-screw internal spinal fixation system, non-sterile
Model / Ref / Catalog
41-8010
Primary DI / UDI-DI
10889981160029
510(k) Number
FDA product code
NKB
GMDN term
Bone-screw internal spinal fixation system, non-sterile
Device class
Class II
Regulation number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone-screw internal spinal fixation system, non-sterile

Cleared under the same submission (K173882)

Show all (12)

Other devices from SeaSpine Orthopedics Corporation

See all devices from SeaSpine Orthopedics Corporation →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number

Other properties (11)

  • Supplied sterile: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No