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Volt

by Synthes GmbH

Ref 02.538.005S, 60.420.000, 03.536.001, 02.538.507S, 02.538.507, 68.529.340, 04.538.511S, 02.538.510S, 60.528.005, 02.538.512, 02.538.506S, 02.538.509, 60.424.007, 02.538.505S, 60.529.340, 60.529.310, 03.536.002, 02.538.511S, 02.538.510, 60.420.007, 04.538.508, 04.538.511, 60.425.005, 03.536.010, 02.538.513S, 60.424.005, 04.538.505S, 60.536.000, 03.536.028, 04.538.509S, 02.538.508, 60.536.005, 68.536.320, 04.538.510S, 02.538.508S, 60.527.001, 60.536.020, 02.538.003S, 60.538.030, 04.538.003S, 02.538.512S, 60.536.012, 04.538.513S, 60.420.005, 60.529.005, 04.420.318, 04.424.140TS, 02.527.390, 04.535.690, 04.420.033Model VOLT Proximal Humerus Plates Stainless Steel, Cases for Trauma/ CMF Devices, Orthopaedic Guides, VOLT Proximal Humerus Plates TiCP, Orthopaedic Sizing Templates, Orthopaedic Sleeves and Drill Guide, VOLT Locking Screws TAV, VOLT Cortex Screws TAV, VOLT Locking Screws Stainless Steel, VOLT Cancellous Screws TAV, VOLT Mini Fragment Plates Commercially Pure Titanium TiCP510(k) K254093

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) K254093↗

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
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK254093 Date10 Mar 2026ClearedStatusActive
European UnionCE/MDR EUDAMED Number7611819a00812JX Basic UDI-DI Date30 Jul 2025RegisteredStatusActive

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  • Withdrawn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
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Device Name
VOLT Proximal Humerus Plates Stainless Steel
Cases for Trauma/ CMF Devices
Orthopaedic Guides
VOLT Proximal Humerus Plates TiCP
Orthopaedic Sizing Templates
Orthopaedic Sleeves and Drill Guide
VOLT Locking Screws TAV
VOLT Cortex Screws TAV
VOLT Locking Screws Stainless Steel
VOLT Cancellous Screws TAV
VOLT Mini Fragment Plates Commercially Pure Titanium TiCP
Model / Reference
VOLT Proximal Humerus Plates Stainless Steel, 02.538.005S, Cases for Trauma/ CMF Devices, 60.420.000, Orthopaedic Guides, 03.536.001, 02.538.507S, 02.538.507, 68.529.340, VOLT Proximal Humerus Plates TiCP, 04.538.511S, 02.538.510S, 60.528.005, 02.538.512, 02.538.506S, 02.538.509, 60.424.007, 02.538.505S, 60.529.340, 60.529.310, 03.536.002, 02.538.511S, 02.538.510, 60.420.007, 04.538.508, 04.538.511, 60.425.005, Orthopaedic Sizing Templates, 03.536.010, 02.538.513S, 60.424.005, 04.538.505S, 60.536.000, Orthopaedic Sleeves and Drill Guide, 03.536.028, 04.538.509S, 02.538.508, 60.536.005, 68.536.320, 04.538.510S, 02.538.508S, 60.527.001, 60.536.020, 02.538.003S, 60.538.030, 04.538.003S, 02.538.512S, 60.536.012, 04.538.513S, 60.420.005, 60.529.005, VOLT Locking Screws TAV, 04.420.318, VOLT Cortex Screws TAV, 04.424.140TS, VOLT Locking Screws Stainless Steel, 02.527.390, VOLT Cancellous Screws TAV, 04.535.690, VOLT Mini Fragment Plates Commercially Pure Titanium TiCP, 04.420.033
Primary DI / UDI-DI
07612334236005, 07612334261984, 07612334229885, 07612334271181, 07612334271174, 07612334262370, 07612334271624, 07612334271242, 07612334262226, 07612334271273, 07612334271167, 07612334271211, 07612334262035, 07612334270924, 07612334262288, 07612334262264, 07612334229892, 07612334271266, 07612334271235, 07612334262004, 07612334271556, 07612334271617, 07612334262158, 07612334236937, 07612334271303, 07612334262028, 07612334270184, 07612334269416, 07612334229908, 07612334271587, 07612334271198, 07612334269423, 07612334269508, 07612334271600, 07612334271204, 07612334269386, 07612334269461, 07612334235985, 07612334272003, 07612334252173, 07612334271280, 07612334269454, 07612334271662, 07612334261991, 07612334262233, 07612334238498, 07612334240125, 07612334253927, 07612334251299, 07612334237231
Basic UDI-DI
7611819a00812JX, 7611819a00012HP, 7611819a00094JK, 7611819a00813JZ, 7611819a00065JC, 7611819a00225JA, 7611819a00665KA, 7611819a00663K6, 7611819a00664K8, 7611819a00667KE, 7611819a00661K2
Direct Marketing DI
07612334261984
07612334229885
07612334262370
07612334262226
07612334262035
07612334262288
07612334262264
07612334229892
07612334262004
07612334262158
07612334236937
07612334262028
07612334269416
07612334229908
07612334269423
07612334269508
07612334269386
07612334269461
07612334272003
07612334269454
07612334261991
07612334262233
510(k) Number
EMDN Code
P09120501, Z12011399, L091001, Z12139099, P09120601, P09120602
Device Class
Class IIb
Class I
Class IIa
EU market of registration
Belgium
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

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

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