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FDA 510(k)

Shoreline Threaded TruProfile® Plate

K-Number: K211903 · 2021-08-30

ApplicantSeaSpine Orthopedics Corporation
Decision Date2021-08-30
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Shoreline Threaded TruProfile® Plate is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2021-08-30 under approval number K211903. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shoreline Threaded TruProfile® Plate?

Shoreline Threaded TruProfile® Plate is a medical device that received FDA 510(k) clearance on 2021-08-30. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K211903.

When was Shoreline Threaded TruProfile® Plate approved by the FDA?

Shoreline Threaded TruProfile® Plate received FDA 510(k) clearance on 2021-08-30, under approval number K211903.

What company makes Shoreline Threaded TruProfile® Plate?

Shoreline Threaded TruProfile® Plate is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for Shoreline Threaded TruProfile® Plate?

The FDA product code for Shoreline Threaded TruProfile® Plate is KWQ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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