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Universal Mesh - Sterile

by Stryker Leibinger GmbH & Co.KG

510(k) K182425

Universal Mesh - Sterile is a Class II device made by Stryker Leibinger GmbH & Co.KG, cleared under FDA 510(k) K182425 on 6 Nov 2018, active as of 8 Nov 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK182425 Date6 Nov 2018ClearedStatusActive

Official records

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1785-2024 FDA Class II initiated 29 Mar 2024

    Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure

Timeline

2 dated events

  1. Cleared FDA 510(k) K182425
  2. Recall initiated FDA recalls Z-1785-2024

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  • Withdrawn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
GWO
FDA applicant
Stryker Leibinger GmbH & Co KG
Device class
Class II
Regulation
21 CFR Part 882.5320
Advisory committee
Neurology
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

Devices cleared under K182425

17 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K182425
UDI-DISize and differences
56-90312S
Stryker Leibinger
56-90312S / 56-90312S07613327382402
Width 40.0 mm; Length 40.0 mm
On the market
56-90314S
Stryker Leibinger
56-90314S / 56-90314S07613327382440
Length 90.0 mm; Width 90.0 mm
On the market
56-90316S
Stryker Leibinger
56-90316S / 56-90316S07613327382419
Width 120.0 mm; Length 120.0 mm
On the market
56-90322S
Stryker Leibinger
56-90322S / 56-90322S07613327382457
Width 40.0 mm; Length 40.0 mm
On the market
56-90324S
Stryker Leibinger
56-90324S / 56-90324S07613327382433
Width 90.0 mm; Length 90.0 mm
On the market
56-90326S
Stryker Leibinger
56-90326S / 56-90326S07613327382426
Width 120.0 mm; Length 120.0 mm
On the market
56-90342S
Stryker Leibinger
56-90342S / 56-90342S07613327382471
Width 60.0 mm; Length 60.0 mm
On the market
56-90344S
Stryker Leibinger
56-90344S / 56-90344S07613327382488
Width 90.0 mm; Length 90.0 mm
On the market
56-90346S
Stryker Leibinger
56-90346S / 56-90346S07613327382532
Length 120.0 mm; Width 120.0 mm
On the market
56-90612S
Stryker Leibinger
56-90612S / 56-90612S07613327382464
Width 40.0 mm; Length 40.0 mm
On the market
56-90614S
Stryker Leibinger
56-90614S / 56-90614S07613327382563
Length 90.0 mm; Width 90.0 mm
On the market
56-90616S
Stryker Leibinger
56-90616S / 56-90616S07613327382549
Length 120.0 mm; Width 120.0 mm
On the market
56-90622S
Stryker Leibinger
56-90622S / 56-90622S07613327382495
Length 40.0 mm; Width 40.0 mm
On the market
56-90624S
Stryker Leibinger
56-90624S / 56-90624S07613327382501
Length 90.0 mm; Width 90.0 mm
On the market
56-90626S
Stryker Leibinger
56-90626S / 56-90626S07613327382556
Length 120.0 mm; Width 120.0 mm
On the market
56-90814S
Stryker Leibinger
56-90814S / 56-90814S07613327382525
Length 90.0 mm; Width 90.0 mm
On the market
56-90816S
Stryker Leibinger
56-90816S / 56-90816S07613327382518
Length 120.0 mm; Width 120.0 mm
On the market

Similar devices

Other devices filed under FDA product code GWO (Plate, Cranioplasty, Preformed, Alterable).

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