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SLiK Anchor 10919

by Parcus Medical LLC

SLiK Anchor 10919 is a Class II device made by Parcus Medical LLC, cleared under FDA 510(k) K170327 on 30 Mar 2017 and listed in FDA GUDID since 29 Nov 2017 (UDI-DI M685109191), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K170327

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM685109191 UDI-DI Date29 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170327 Date30 Mar 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170327 decided 30 Mar 2017 Active
  • FDA GUDID UDI-DI M685109191 listed 29 Nov 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170327
  2. Listed FDA GUDID M685109191

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SLiK Anchor
Generic name
Tendon/ligament bone anchor, non-bioabsorbable
Model / Ref / Catalog
10919
Primary DI / UDI-DI
M685109191
510(k) Number
FDA product code
MBI
GMDN term
Tendon/ligament bone anchor, non-bioabsorbable
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Length — 15 Millimeter
Outer Diameter — 6.25 Millimeter

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 Tendon/ligament bone anchor, non-bioabsorbable.

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 (9, all answered No)