Mariner MIS

FDA UDI

Class II (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name: Mariner MIS FDA UDI
Generic Name: Orthopaedic implant driver FDA UDI
Device Name: MIS NAVIGATION DRIVER FDA UDI
Model / Reference: MM2-000190 FDA UDI
Description: MIS NAVIGATION DRIVER FDA UDI

Identifiers

Catalog Number: MM2-000190 FDA UDI
Primary DI / UDI-DI: 10889981178208 FDA UDI
510(k) Number: K191648 FDA UDI
FDA Product Code: OLO FDA UDI
KWQ FDA UDI
NKB FDA UDI
GMDN Term: Orthopaedic implant driver FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
888.3060 FDA UDI
888.3070 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic implant driver

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

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: SeaSpine Orthopedics Corporation

Sources (1)

FDA UDI e003cf65-c64d-4c6a-b78f-c87ed034bfe6 35 fields · synced Jun 8, 2026