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Sps 432006

by Stryker Corp.

Ref 432006Model 08858251005325T6

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251005325T6 Basic UDI-DI 04546540069702UDI-DIDate16 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540069702 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
SPS™ Large Fragment EUDAMED
Sps GUDID
Generic Name
Orthopaedic fixation plate, non-bioabsorbable
Device Name
Sps Large Fragment - Plate - Stainless Steel - Class Iib - Non Sterile
Model / Ref / Catalog
432006, 08858251005325T6
Primary DI / UDI-DI
04546540069702
Basic UDI-DI
08858251005325T6
510(k) Number
FDA Product Code
HRS, HWC
EMDN Code
P09120599 Bone fixation plates - other
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3030, 888.3040
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 110.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K012162)

Show all (12)

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Single Use
  • Implantable
  • Sutures
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number

Other properties (19)

  • Sterile: No
  • Reusable: No
  • 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
  • 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