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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 the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2021-08-30 under 510(k) 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. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K211903.

When did Shoreline Threaded TruProfile® Plate receive FDA 510(k) clearance?

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

Who is the listed applicant for Shoreline Threaded TruProfile® Plate?

The FDA 510(k) record lists SeaSpine Orthopedics Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing SeaSpine Orthopedics Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SyK250908Virata Spinal Fixation SystemK243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsK242273Cove Putty, OsteoCove PuttyK241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody SystemK240566Reef L Interbody System; WaveForm L Interbody System

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Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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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