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Mariner Deformity MD3-006019

by SeaSpine Orthopedics Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

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 Number10889981274139 UDI-DI Date25 Aug 2021ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-3226-2026 FDA Class II initiated 19 Aug 2026

    The proximal thread depth of the spinal device is out of design specification.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Mariner Deformity
Generic Name
Instrument tray, reusable
Model / Ref / Catalog
MD3-006019
Primary DI / UDI-DI
10889981274139
510(k) Number
FDA Product Code
KWQ, NKB, KWP
GMDN Term
Instrument tray, reusable
Device Class
Class II
Regulation Number
888.3060, 888.3070, 888.3050
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Instrument tray, reusable

Cleared under the same submission (K211606)

Show all (12)

Other devices from SeaSpine Orthopedics Corporation

See all devices from SeaSpine Orthopedics Corporation →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: 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