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
00199150077359Medtronic Reusable InstrumentsEX02260492026-06-01
00199150077366Medtronic Reusable InstrumentsEX02260512026-06-01
00763000857844T2 STRATOSPHERE™ Expandable Corpectomy System43612552026-06-01
00763000857943T2 STRATOSPHERE™ Expandable Corpectomy System43612202026-06-01
00763000857998T2 STRATOSPHERE™ Expandable Corpectomy System43613082026-06-01
00763000881252Clydesdale™ Spinal System49860402026-05-29
00199150073504Medtronic Reusable InstrumentsEX12250012026-05-25
00199150071685Medtronic Reusable InstrumentsEX02261402026-05-24
00199150071692Medtronic Reusable InstrumentsEX02261502026-05-24
00199150071708Medtronic Reusable InstrumentsEX02261602026-05-24
00199150071715Medtronic Reusable InstrumentsEX02261702026-05-24
00199150071722Medtronic Reusable InstrumentsEX02261802026-05-24
00199150071739Medtronic Reusable InstrumentsEX02261902026-05-24
00199150071746Medtronic Reusable InstrumentsEX02262002026-05-24
00199150071753Medtronic Reusable InstrumentsEX02260402026-05-24
00199150071760Medtronic Reusable InstrumentsEX02260502026-05-24
00199150071777Medtronic Reusable InstrumentsEX02260602026-05-24
00199150071784Medtronic Reusable InstrumentsEX02260702026-05-24
00199150071791Medtronic Reusable InstrumentsEX02260802026-05-24
00199150071807Medtronic Reusable InstrumentsEX02260902026-05-24

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