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MatrixSTERNUM

by Synthes GmbH

Ref 03.501.450, 03.501.445, 60.133.600, 03.501.449, 68.501.136, 03.501.451, 03.501.443, 60.501.128, 03.501.448, 60.501.129, 03.501.441, 04.501.415.01, 04.501.417.01, 04.501.412.01, 04.501.316S, 04.501.414.01TS, 04.501.329, 04.501.420.01TS, 04.501.430.01, 04.501.417.01TS, 04.501.318S, 04.501.415.01TS, 04.501.334, 04.501.318, 04.501.410.01, 04.501.418.01, 04.501.419.01, 04.501.331, 04.501.409.01, 04.501.320S, 04.501.325S, 04.501.322S, 03.501.453, 04.501.412.01TS, 04.501.334S, 60.501.126, 04.501.419.01TS, 04.501.316, 04.501.331S, 04.501.304, 04.501.304S, 04.501.413.01TS, 04.501.430.01TS, 04.501.322, 04.501.320, 04.501.338SModel Orthopaedic Bending Driver, Orthopaedic Reduction Forceps, Cases for Trauma/ CMF Devices, Orthopaedic Sleeves and Drill Guide, Orthopaedic Instrument Handles, Orthopaedic Bending Pliers, MatrixSTERNUM Screws, MatrixSTERNUM Thoracotomy Plates, MatrixSTERNUM Sternal Body Plates510(k) K233967

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K233967↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number7611819a00368JZ Basic UDI-DI Date3 Dec 2025RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK233967 Date9 May 2024ClearedStatusActive

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 25 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Device Name
Orthopaedic Bending Driver
Orthopaedic Reduction Forceps
Cases for Trauma/ CMF Devices
Orthopaedic Sleeves and Drill Guide
Orthopaedic Instrument Handles
Orthopaedic Bending Pliers
MatrixSTERNUM Screws
MatrixSTERNUM Thoracotomy Plates
MatrixSTERNUM Sternal Body Plates
Model / Reference
Orthopaedic Bending Driver, 03.501.450, Orthopaedic Reduction Forceps, 03.501.445, Cases for Trauma/ CMF Devices, 60.133.600, 03.501.449, 68.501.136, Orthopaedic Sleeves and Drill Guide, 03.501.451, Orthopaedic Instrument Handles, 03.501.443, 60.501.128, Orthopaedic Bending Pliers, 03.501.448, 60.501.129, 03.501.441, MatrixSTERNUM Screws, 04.501.415.01, 04.501.417.01, 04.501.412.01, MatrixSTERNUM Thoracotomy Plates, 04.501.316S, 04.501.414.01TS, MatrixSTERNUM Sternal Body Plates, 04.501.329, 04.501.420.01TS, 04.501.430.01, 04.501.417.01TS, 04.501.318S, 04.501.415.01TS, 04.501.334, 04.501.318, 04.501.410.01, 04.501.418.01, 04.501.419.01, 04.501.331, 04.501.409.01, 04.501.320S, 04.501.325S, 04.501.322S, 03.501.453, 04.501.412.01TS, 04.501.334S, 60.501.126, 04.501.419.01TS, 04.501.316, 04.501.331S, 04.501.304, 04.501.304S, 04.501.413.01TS, 04.501.430.01TS, 04.501.322, 04.501.320, 04.501.338S
Primary DI / UDI-DI
07612334259073, 07612334229830, 07612334263483, 07612334230164, 07612334295675, 07612334263452, 07612334229816, 07612334263537, 07612334230157, 07612334263544, 07612334229793, 07612334230652, 07612334230690, 07612334230591, 07612334230225, 07612334230645, 07612334230379, 07612334230768, 07612334230775, 07612334230706, 07612334230249, 07612334230669, 07612334230454, 07612334230232, 07612334230553, 07612334230713, 07612334230737, 07612334230416, 07612334230539, 07612334230263, 07612334230348, 07612334230287, 07612334263476, 07612334230607, 07612334230461, 07612334263513, 07612334230744, 07612334230218, 07612334230423, 07612334230171, 07612334230188, 07612334230621, 07612334230782, 07612334230270, 07612334230256, 07612334230508
Basic UDI-DI
7611819a00368JZ, 7611819a00045J6, 7611819a00012HP, 7611819a00225JA, 7611819a00099JV, 7611819a00102HR, 7611819a00830JZ, 7611819a00829KG, 7611819a00828KE
Direct Marketing DI
07612334259073
07612334229830
07612334263483
07612334230164
07612334295675
07612334263452
07612334229816
07612334263537
07612334230157
07612334263544
07612334229793
07612334230652
07612334230690
07612334230591
07612334230218
07612334230638
07612334230379
07612334230751
07612334230775
07612334230232
07612334230454
07612334230553
07612334230713
07612334230737
07612334230416
07612334230539
07612334230256
07612334230331
07612334230270
07612334263476
07612334263513
07612334230171
07612334230614
07612334230492
510(k) Number
FDA Product Code
HRS
EMDN Code
L091001, Z12011399, P09120601, P09120501
Device Class
Class I EUDAMED
Class IIb EUDAMED
Class II 510(k)
Regulation
21 CFR Part 888.3030
EU market of registration
Belgium
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class I
Class IIb
510(k)
Class II

Manufacturer details

EUDAMED SRN
CH-MF-000013345
Authorised representative
DePuy Ireland UC IE-AR-000009328

Other devices from Synthes GmbH

See all devices from Synthes GmbH →

Properties

  • Sterile NoEUDAMEDYesEUDAMED
  • Implantable NoEUDAMEDYesEUDAMED
  • Reusable YesEUDAMEDNoEUDAMED
  • Sutures
  • CMR Substance YesEUDAMEDNoEUDAMED

Other properties (9)

  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No