FDA.reportPublic FDA data

Pyramesh® Implant System

Primary DI
00673978080574
Brand
Pyramesh® Implant System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
905-103
Device description
MESH 905-103 PYRM 10MM X 30MM ROUND
Published
2015-08-24
Public version status
Update
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
MQPSpinal vertebral body replacement device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZXMesh, Surgical, MetalGeneral, Plastic Surgery2
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183197000
K890601000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183197000PYRAMESH™ Implant SystemMedtronic Sofamor Danek USA, Inc.2019-04-04MQP
K890601000STUART TITANIUM SURGICAL MESHStuart1989-03-16EZX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673978080574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673978080574006739780805746739780805740673978080574

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, metallicA sterile flat woven/knitted material made of a biocompatible metal (e.g., surgical stainless steel, tantalum) with appropriate mechanical characteristics for implantation. This non-dedicated device is used alone or in combination with synthetic materials (e.g., polymers) 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). Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Millimeter
Outer Diameter10Millimeter

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
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00763000311698KYPHON® EXPRESS™ Directional Bone Filler DeviceF06B2020-11-06
0076300031183413 Ga TampVPT02A2020-11-06
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00763000712006N/A65500432024-12-28
00763000712013N/A65500442024-12-28
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00763000311650KYPHON® Bone Filler Device (BFD)F04B2020-11-06
20643169842735KYPHON ELEMENT™ Balloon Kyphoplasty System7480703T2023-06-03
00613994946393n/aEX08108162022-11-21
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00643169100749Medtronic Reusable InstrumentsCDS2A2022-10-15
00643169100756KYPHON® Cement Delivery SystemCC02A2022-10-15
00763000590970Kyphon VuE Bone Cement and Kyphon MixerCT01B2022-07-25

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Primary DI, Brand, Company table
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00763000857950T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-10-11
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10888857223967CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
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