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Mariner RDX MIS MX1-001010

by SeaSpine Orthopedics Corporation

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 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 Number10889981298647 UDI-DI Date24 Mar 2023ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1620-2024 FDA Class II initiated 28 Feb 2024

    Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.

    • Ongoing Z-1605-2024 FDA Class II initiated 15 Feb 2024

    Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Mariner RDX MIS
Generic Name
Bone-screw internal spinal fixation system, non-sterile
Model / Ref / Catalog
MX1-001010
Primary DI / UDI-DI
10889981298647
510(k) Number
FDA Product Code
KWQ, NKB, KWP
GMDN Term
Bone-screw internal spinal fixation system, non-sterile
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: Bone-screw internal spinal fixation system, non-sterile

Cleared under the same submission (K222110)

Show all (12)

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • 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