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Mariner Cortical

FDA UDI

Class II (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name
Mariner Cortical FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
CORTICAL SHANK, Cannulated, 8.5 X 30 FDA UDI
Model / Reference
MC1-185030 FDA UDI
Description
CORTICAL SHANK, Cannulated, 8.5 X 30 FDA UDI

Identifiers

Catalog Number
MC1-185030 FDA UDI
Primary DI / UDI-DI
10889987169224 FDA UDI
510(k) Number
K173882 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

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

Cleared under the same submission

K173882 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 8a34621a-caf9-4362-b634-fdfdf2c0b3c0 37 fields · synced Jun 8, 2026