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SutureLoc™ Implant

by Arthrex, Inc.

510(k) K223284

SutureLoc™ Implant is a Class II device made by Arthrex, Inc., cleared under FDA 510(k) K223284 on 2 Feb 2023, active as of 25 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK223284 Date2 Feb 2023ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MBI
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue).

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