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Raven Lumbar Plate System

by Choicespine, LP

510(k) K183214

Active United States. Also listed in GUDID (US).

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), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00840996177092 UDI-DI Date20 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK183214 Date3 Jan 2019ClearedStatusActive

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  • Withdrawn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) · GUDID

Generic Name
Spinal fixation plate, non-bioabsorbable
Model / Reference
Y070-1000
Primary DI / UDI-DI
00840996177092
510(k) Number
FDA Product Code
KWQ 510(k)
LXH GUDID
GMDN Term
Spinal fixation plate, non-bioabsorbable
Device Class
Class II 510(k)
Class I GUDID
Regulation
21 CFR Part 888.3060 510(k)
888.4540 GUDID
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 3 fields differ

Field510(k)GUDID
FDA Product Code510(k)
KWQ
GUDID
LXH
Device Class510(k)
Class II
GUDID
Class I
Regulation Number510(k)
888.3060
GUDID
888.4540

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 Raven Lumbar Plate System is a spinal fixation device classified as an Anterior Lumbar Interbody Fusion Device (per FDA nomenclature). It is designed to stabilize the lumbar spine through anterior placement, aiding in spinal fusion by maintaining segmental alignment and load sharing. The system includes buttress plates and compatible implants intended for use at levels T1 to S1. Its primary function is to provide temporary stabilization and augment a solid spinal fusion, either as a standalone solution or in conjunction with other spinal systems.

This system is supplied sterile and intended for single-use. It is approved under FDA 510(k) clearance (K183214) as substantially equivalent to a predicate device, with a Traditional review pathway through the Orthopedic (OR) Advisory Committee. The Raven Lumbar Plate System features a Cam Locking Mechanism for secure fixation and is compatible with anterior, anterolateral, or posterior spinal systems. Storage and handling must adhere to sterile processing protocols to ensure device integrity prior to surgical use.

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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 Raven Lumbar Plate System used for?

    The Raven Lumbar Plate System is designed to stabilize the lumbar spine through anterior placement, aiding in spinal fusion by maintaining segmental alignment and load sharing. It provides temporary stabilization to support a solid spinal fusion, either as a standalone solution or in combination with other spinal systems. This approach helps ensure proper spinal alignment during the healing process.

  • How is the Raven Lumbar Plate System supplied and intended for use?

    The system is supplied sterile and is intended for single-use only. This ensures optimal sterility and safety for surgical procedures, reducing the risk of infection and contamination. Adherence to sterile processing protocols during storage and handling is critical to maintain device integrity before use.

  • What levels of the spine is the Raven Lumbar Plate System compatible with?

    The Raven Lumbar Plate System is compatible with spinal levels from T1 (thoracic 1) through S1 (sacral 1). This broad range allows surgeons to address various lumbar and lower thoracic spinal conditions with a single system, ensuring flexibility in treatment planning.

  • What distinguishes the fixation mechanism of the Raven Lumbar Plate System?

    The Raven Lumbar Plate System features a Cam Locking Mechanism, which provides secure and stable fixation. This design ensures that the plate remains firmly in place during the fusion process, reducing the risk of loosening or displacement and promoting optimal healing conditions.

  • How should the Raven Lumbar Plate System be stored?

    The Raven Lumbar Plate System must be stored and handled according to strict sterile processing protocols. This includes maintaining the sterile packaging until the time of use and ensuring the environment is free from contamination. Proper storage conditions help preserve the device’s integrity and functionality for surgical procedures.

Properties

  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No