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Sc 5816-85-2

by aap Implantate AG

Ref SC 5816-85-2Model Bone screws (non-sterile)

Sc 5816-85-2 is a device classified as Class IIb in the EU and Class II in the US made by aap Implantate AG, registered in EUDAMED on 2 Oct 2026 (Basic UDI-DI B-04042409096518), cleared under FDA 510(k) K111316 on 20 Jul 2011 and listed in FDA GUDID since 18 Aug 2016 (UDI-DI 04042409096518), active as of 23 Oct 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K111316

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04042409096518 Basic UDI-DI 04042409096518UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04042409096518 UDI-DI Date18 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK111316 Date20 Jul 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04042409096518 registered 2 Oct 2026 Active
  • FDA 510(k) K111316 decided 20 Jul 2011 Active
  • FDA GUDID UDI-DI 04042409096518 listed 18 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K111316
  2. Listed FDA GUDID 04042409096518
  3. Registered EUDAMED B-04042409096518

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  • Withdrawn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

Generic name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
SC 5816-85-2, Bone screws (non-sterile)
Primary DI / UDI-DI
04042409096518
Basic UDI-DI
B-04042409096518
510(k) Number
FDA product code
HWC
EMDN code
P09120603 Cannulated screws
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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 bone screw (non-sliding)

Cleared under the same submission (K111316)

and 8 more cleared under K111316

Similar devices in this category

Other devices filed under CANNULATED SCREWS.

Other devices from aap Implantate AG

See all devices from aap Implantate AG →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)