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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
Internal spinal fixation system cable tensioner FDA UDI
Device Name
Mariner Cap SP Crimper FDA UDI
Model / Reference
569326 FDA UDI
Description
Mariner Cap SP Crimper FDA UDI

Identifiers

Catalog Number
569326 FDA UDI
Primary DI / UDI-DI
10889981220945 FDA UDI
510(k) Number
K201240 FDA UDI
FDA Product Code
OWI FDA UDI
GMDN Term
Internal spinal fixation system cable tensioner 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

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: Internal spinal fixation system cable tensioner

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

Similar devices

Also classified as Internal spinal fixation system cable tensioner.

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 8749bd15-745c-406f-a00a-31904beb3adc 36 fields · synced Jun 8, 2026