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CODA Anterior Cervical Plate System

by Pioneer Surgical Technology, Inc.

510(k) K222493Ref 2022-01-999, 2022-20-500Model 2022-01-599, 2022-20-400

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 26 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222493↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number019108304020IN0054N Basic UDI-DI Date4 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840298700691 UDI-DI Date19 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK222493 Date18 Nov 2022ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Surgical drill guide, reusable
Bone awl, reusable
Model / Ref / Catalog
2022-01-599, 2022-01-999, 2022-20-400, 2022-20-500, 58-202201999, 58-202220500
Primary DI / UDI-DI
00840298700691, 00840298700646
Basic UDI-DI
019108304020IN0054N, 019108304020IN0014E
510(k) Number
FDA Product Code
KWQ 510(k)
FZX GUDID
HWJ GUDID
EMDN Code
L0922, L091001
GMDN Term
Surgical drill guide, reusable
Bone awl, reusable
Device Class
Class I EUDAMEDGUDID
Class II 510(k)
Regulation
21 CFR Part 888.3060 510(k)
878.4800 GUDID
888.4540 GUDID
EU market of registration
Germany
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

3 sources · 4 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
2022-01-599
2022-01-999
2022-20-400
2022-20-500
510(k)
—
GUDID
58-202201999
58-202220500
FDA Product CodeEUDAMED
—
510(k)
KWQ
GUDID
FZX
HWJ
Device ClassEUDAMED
Class I
510(k)
Class II
GUDID
Class I
Regulation NumberEUDAMED
—
510(k)
888.3060
GUDID
878.4800
888.4540

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 CODA Anterior Cervical Plate System is an orthopedic device classified as an anterior cervical plate for spinal fixation. It is designed to provide rigid stabilization of the cervical spine (C2–C7) as an adjunct to fusion in skeletally mature patients, featuring an integrated active locking mechanism for screw fixation.

The system is supplied sterile and reusable, with plates available in multiple lengths to accommodate varying anatomical requirements. It is intended for use in operating rooms under sterile conditions and must comply with FDA 510(k) clearance (K222493) and MDR regulations. MRI safety and specific size configurations are detailed in the manufacturer’s instructions for use.

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Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No