FDA.reportPublic FDA data

Pyramesh® Implant System

Primary DI
00763000856625
Brand
Pyramesh® Implant System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
905-902
Device description
MESH 905-902 PYRM 10X14 OVOIDX130MM CRV
Published
2025-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZXMesh, surgical, metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZXMesh, Surgical, MetalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K890601000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K890601000STUART TITANIUM SURGICAL MESHStuart1989-03-16EZX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000856625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000856625007630008566257630008566250763000856625

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, metalA non-bioabsorbable, implantable material (e.g., flat sheet) made from made from a biocompatible metal, with appropriate mechanical characteristics for implantation, intended for an extra-gynaecological tissue repair/reinforcement application(s) to support or protect tissues in reconstructive surgical procedures (e.g., to repair large chest wall defects or large abdominal incisional hernias) and/or orthopaedic procedures (e.g., cranioplasty, femoral reconstruction); it is not primarily intended for dental use. Disposable devices associated with implantation may be supplied with the mesh.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169236967n/a74806532026-10-11
00643169236974n/a74806522026-10-11
00643169236981n/a74806512026-10-11
00763000857851T2 STRATOSPHERE™ Expandable Corpectomy System43612582026-10-11
00763000857950T2 STRATOSPHERE™ Expandable Corpectomy System43612252026-10-11
00763000874209MSB SHILLA Growth Guidance System76745002026-10-11
00763000885502MSB Reusable Instruments7080921D2026-10-11
00824846010722Medtronic Reusable InstrumentsX07260022026-10-09
00643169964938GRAFTON™ DBMT42275INT2024-12-05
00643169965102GRAFTON PLUS™ DBMT45005INT2024-11-15
00763000140502PROGENIX™ PUTTY and PROGENIX™ PLUS0005052021-03-12
00763000140519PROGENIX™ PUTTY and PROGENIX™ PLUS0050012021-03-12
00763000140526PROGENIX™ PUTTY and PROGENIX™ PLUS0050052021-03-12
00763000140533PROGENIX™ PUTTY and PROGENIX™ PLUS0051102021-03-12
00763000140540PROGENIX™ PUTTY and PROGENIX™ PLUS0060012021-03-12
00763000140557PROGENIX™ PUTTY and PROGENIX™ PLUS0060022021-03-12
00763000140564PROGENIX™ PUTTY and PROGENIX™ PLUS0060052021-03-12
00763000140571PROGENIX™ PUTTY and PROGENIX™ PLUS0060102021-03-12
00643169965089GRAFTON® DBMT44150INT2019-02-07
00613994247612PROGENIX® PUTTY and PROGENIX® PLUS0051102019-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000855444Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-27
00763000855451Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-27
00763000855468Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-27
00763000855475Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-27
00763000855499Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-27
00763000856403Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-27
00763000856410Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-27
00763000856458Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-27
00763000856465Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-27
00763000856397PYRAMESH® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-25
00763000856472Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856489Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856502Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856519Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856526Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856533Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856557Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856564Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856571Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856588Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856595Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856632Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000856649Pyramesh® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-18
00763000855260PYRAMESH® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-10
00763000855284PYRAMESH® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-10
00763000855291PYRAMESH® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-10
00763000855307PYRAMESH® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-10
00763000855314PYRAMESH® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-10
00763000855321PYRAMESH® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-10
00763000855352PYRAMESH® Implant SystemMEDTRONIC SOFAMOR DANEK, INC.EZX2025-07-10