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Slik Anchor 10915

by Parcus Medical LLC

Ref 10915

Slik Anchor 10915 is a device classified as Class IIb in the EU and Class II in the US made by Parcus Medical LLC, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI B-00816342023375), cleared under FDA 510(k) K170327 on 30 Mar 2017 and listed in FDA GUDID since 27 Jul 2023 (UDI-DI 00816342023375), 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) K170327

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-00816342023375 Basic UDI-DI 00816342023375UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816342023375 UDI-DI Date27 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170327 Date30 Mar 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00816342023375 registered 23 Oct 2026 Active
  • FDA 510(k) K170327 decided 30 Mar 2017 Active
  • FDA GUDID UDI-DI 00816342023375 listed 27 Jul 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170327
  2. Listed FDA GUDID 00816342023375
  3. Registered EUDAMED B-00816342023375

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  • Withdrawn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
4.75 SLiK PEEK ANCHOR EUDAMED
Slik Anchor GUDID
Generic name
Tendon/ligament bone anchor, non-bioabsorbable
Device name
Slik PEEK Anchors
Model / reference
10915
Primary DI / UDI-DI
00816342023375
Basic UDI-DI
B-00816342023375
510(k) Number
FDA product code
MBI
EMDN code
P09120102 Anchors, tendon and ligament synthesis
GMDN term
Tendon/ligament bone anchor, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

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: Tendon/ligament bone anchor, non-bioabsorbable

Cleared under the same submission (K170327)

and 8 more cleared under K170327

Similar devices in this category

Other devices filed under ANCHORS, TENDON AND LIGAMENT SYNTHESIS.

Other devices from Parcus Medical LLC

See all devices from Parcus Medical LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)