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Mariner Cap

FDA UDI

Class II (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name
Mariner Cap FDA UDI
Generic Name
Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Device Name
Mariner Cap SP FDA UDI
Model / Reference
369690 FDA UDI
Description
Mariner Cap SP FDA UDI

Identifiers

Catalog Number
369690 FDA UDI
Primary DI / UDI-DI
10889981220907 FDA UDI
510(k) Number
K201240 FDA UDI
FDA Product Code
OWI FDA UDI
GMDN Term
Trans-facet-screw internal spinal fixation system, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Trans-facet-screw internal spinal fixation system, sterile

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

Similar devices

Also classified as Trans-facet-screw internal spinal fixation system, sterile.

Cleared under the same submission

K201240 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 daea39cb-f76f-4d25-bd62-da1d891ca051 36 fields · synced Jun 8, 2026