Atlas FDA

Universal Mesh - Sterile

FDA 510(k) clearance K182425 · decided 2018-11-06

Clearance details

K-number
K182425
Device name
Universal Mesh - Sterile
Applicant
Stryker Leibinger GmbH & Co KG
Decision
Substantially Equivalent
Date received
2018-09-06
Decision date
2018-11-06
Days to decision
61 days
Clearance type
Special
Product code
GWO
Device class
2
Regulation number
882.5320
Medical specialty
Neurology
Advisory committee
Neurology
Location
Freiburg, DE
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization recall (Z-1785-2024)Stryker Leibinger GmbH & Co. KG2024-05-08

PMA approvals by this applicant

RecordFirmDate
Adherus AutoSpray Dural Sealant (P130014/S021)Stryker Leibinger GmbH & Co KG2025-11-06
TMJ Concepts Patient Fitted Temporomandibular Joint (TMJ) Reconstruction Prosthesis System (P980052/S016)Stryker Leibinger, GmbH & Co KG2025-07-23
Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S020)Stryker Leibinger GmbH & Co KG2024-08-29
TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis (P980052/S015)Stryker Leibinger, GmbH & Co KG2024-08-08
TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis (P980052/S014)Stryker Leibinger, GmbH & Co KG2024-07-30
Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S019)Stryker Leibinger GmbH & Co KG2023-10-07
Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S018)Stryker Leibinger GmbH & Co KG2023-08-25
TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) st (P980052/S012)Stryker Leibinger, GmbH & Co KG2023-08-22