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CoFix System

by Paradigm Spine GmbH

510(k) K201704

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 · Special NumberK201704 Date4 Aug 2020ClearedStatusActive

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  • Withdrawn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, 18 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 CoFix System is a Spinous Process Plate, a posterior supplemental fixation device designed to provide stability to the spine. It is intended for use as an adjunct to interbody fusion at a single lumbar level (L1–S1), offering mechanical reinforcement without pedicle screw fixation.

The system is supplied sterile and intended for single-use in orthopedic surgical settings. It is classified as a Class II medical device under FDA regulations (510(k) clearance, K201704) and must be used in accordance with approved surgical protocols. Multiple plate sizes and configurations are available, as referenced by the listed FEI numbers.

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