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SeaSpine Spinous Process System

by SeaSpine Orthopedics Corporation

510(k) K173334

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 NumberK173334 Date22 Feb 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  • Withdrawn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
PEK
Device class
Class II
Regulation
21 CFR Part 888.3050
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 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 Spinous Process System is a posterior, non-pedicle supplemental fixation device classified as a Spinous Process Plate (product code PEK). It is designed to provide spacing between adjacent spinous processes in the non-cervical spine (T1–S1), promoting bone fusion and limiting spinal extension. The system is intended for single-level use and includes implants and instrumentation for surgical placement.

The device is supplied as a sterile, single-use system and is regulated under FDA 510(k) clearance (K173334) as a Class II medical device under regulation 888.3050. It is intended for use in orthopedic surgical settings and requires proper handling and storage as per manufacturer guidelines. No MRI safety information is specified in the available data.

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Questions

AI-generated answers, 1 Oct 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 Spinous Process System used for?

    The SeaSpine Spinous Process System is a posterior, non-pedicle supplemental fixation device intended to create spacing between adjacent spinous processes in the non-cervical spine (from T1 to S1). This promotes bone fusion and helps limit spinal extension, supporting spinal stability during the healing process. It is specifically designed for single-level use in orthopedic surgical settings.

  • How is the SeaSpine Spinous Process System supplied and prepared for use?

    The system is supplied as a sterile, single-use device. This ensures sterility and reduces the risk of infection, as it is not intended for reuse. Proper handling and adherence to manufacturer guidelines are required to maintain sterility before and during surgical procedures.

  • Is the SeaSpine Spinous Process System reusable or single-use?

    The SeaSpine Spinous Process System is explicitly designed for single-use only. This classification aligns with FDA 510(k) clearance (K173334) and manufacturer recommendations to ensure patient safety and sterility. Reuse is not permitted.

  • What spinal levels does the SeaSpine Spinous Process System target?

    The device is intended for use in the non-cervical spine, spanning from the first thoracic vertebra (T1) to the first sacral vertebra (S1). It is not designed for cervical spine applications or multi-level procedures.

  • How should the SeaSpine Spinous Process System be stored?

    The SeaSpine Spinous Process System must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. This typically includes keeping the packaging intact, storing in a clean, dry environment, and avoiding exposure to extreme temperatures or moisture. Always refer to the provided instructions for precise storage instructions.