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Mariner RDX

FDA UDI

Class II (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name
Mariner RDX FDA UDI
Generic Name
Orthopaedic rod reducer FDA UDI
Device Name
Mariner RDX Reducer Extension FDA UDI
Model / Reference
MX2-000080 FDA UDI
Description
Mariner RDX Reducer Extension FDA UDI

Identifiers

Catalog Number
MX2-000080 FDA UDI
Primary DI / UDI-DI
10889981289942 FDA UDI
510(k) Number
K222110 FDA UDI
FDA Product Code
KWP FDA UDI
KWQ FDA UDI
NKB FDA UDI
GMDN Term
Orthopaedic rod reducer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3050 FDA UDI
888.3060 FDA UDI
888.3070 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic rod reducer

Mariner RDX by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic rod reducer.

Cleared under the same submission

K222110 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SeaSpine Orthopedics Corporation

Sources (1)

  • FDA UDI cf93b90f-bfa8-4050-8f3f-bb1e1450e8be 36 fields · synced Jun 8, 2026