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SeaSpine Regatta Lateral System

by SeaSpine Orthopedics Corporation

510(k) K181079

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181079 Date18 Jul 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MAX
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SeaSpine Regatta Lateral System is an orthopedic device used for spinal surgery. It is designed to provide lateral access and fixation for spinal procedures.

The system is supplied by SeaSpine Orthopedics Corporation and is authorized under FDA 510K clearance. It is available in various sizes and models as specified by the manufacturer.

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Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SeaSpine Regatta Lateral System used for?

    The SeaSpine Regatta Lateral System is an orthopedic device designed to provide lateral access and fixation for spinal procedures. It is specifically manufactured for use in spinal surgeries to help stabilize and support the spine.

  • What sizes and models are available for the SeaSpine Regatta Lateral System?

    The SeaSpine Regatta Lateral System is available in various sizes and models as specified by the manufacturer, SeaSpine Orthopedics Corporation. The specific sizing options would be detailed in the product documentation provided with the system.

  • What is the regulatory status of the SeaSpine Regatta Lateral System?

    The SeaSpine Regatta Lateral System is authorized under FDA 510K clearance with the K-number K181079. It received FDA clearance on July 18, 2018, and is classified under product code MAX.

  • Who manufactures the SeaSpine Regatta Lateral System?

    The SeaSpine Regatta Lateral System is manufactured by SeaSpine Orthopedics Corporation, located at 5770 Armada Dr., Carlsbad, CA 92008. The company can be contacted through Gina Flores for any inquiries regarding the product.