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FDA 510(k)

SeaSpine Regatta Lateral System

K-Number: K181079 · 2018-07-18

ApplicantSeaSpine Orthopedics Corporation
Decision Date2018-07-18
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SeaSpine Regatta Lateral System 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 2018-07-18 under 510(k) number K181079. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SeaSpine Regatta Lateral System?

SeaSpine Regatta Lateral System is a medical device that received FDA 510(k) clearance on 2018-07-18. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K181079.

When did SeaSpine Regatta Lateral System receive FDA 510(k) clearance?

SeaSpine Regatta Lateral System received FDA 510(k) clearance on 2018-07-18, under 510(k) number K181079.

Who is the listed applicant for SeaSpine Regatta Lateral System?

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 SeaSpine Regatta Lateral System?

The FDA product code for SeaSpine Regatta Lateral System is MAX.

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: MAX)

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.

K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.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 SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.

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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