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Acumed Pl-SA06R

by Acumed LLC

Ref PL-SA06R

Acumed Pl-SA06R is a device classified as Class IIb in the EU and Class II in the US made by Acumed LLC, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-10806378077258), cleared under FDA 510(k) K051083 on 12 May 2005 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 10806378077258), active as of 7 Nov 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K051083

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10806378077258 Basic UDI-DI 10806378077258UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10806378077258 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK051083 Date12 May 2005DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10806378077258 registered 26 Oct 2026 Active
  • FDA 510(k) K051083 decided 12 May 2005 Active
  • FDA GUDID UDI-DI 10806378077258 listed 24 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K051083
  2. Listed FDA GUDID 10806378077258
  3. Registered EUDAMED B-10806378077258

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Acumed
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Device name
Plate
Model / reference
PL-SA06R
Primary DI / UDI-DI
10806378077258
Basic UDI-DI
B-10806378077258
510(k) Number
FDA product code
HRS
EMDN code
P09120502 Osteosynthesis neutralisation and support plates
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3030
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Supplied sterileEUDAMED
Yes
GUDID
No
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 10806378077258: EUDAMED states Yes, FDA GUDID states No.
  • Sterilise before use UDI-DI 10806378077258: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K051083)

and 8 more cleared under K051083

Similar devices in this category

Other devices filed under BONE FIXATION PLATES.

Other devices from Acumed LLC

See all devices from Acumed LLC →

Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (19, all answered No)