FDA.reportPublic FDA data

PYRAMESH® C Titanium Mesh

Primary DI
00763000856656
Brand
PYRAMESH® C Titanium Mesh
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
905-800
Device description
MESH 905-800 PYRM END RING SET SCRW
Published
2025-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQPSpinal vertebral body replacement device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011406000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011406000SPINAL MESH SYSTEMMedtronic Sofamor Danek, Inc.2001-12-27MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000856650PrimaryGS10
00763000856656Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300085665020763000856650
00763000856656007630008566567630008566560763000856656

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
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000750282CD HORIZON® Fenestrated Screw Spinal System557510255452026-11-01
00763000750411CD HORIZON® Fenestrated Screw Spinal System557510265552026-11-01
00763000750497MSB CD HORIZON® Fenestrated Screw Spinal System557510275402026-10-31
00763000750503CD HORIZON® Fenestrated Screw Spinal System557510275452026-11-01
00763000774165CD HORIZON Spinal System557500165302026-10-31
00763000774172MSB CD HORIZON Spinal System557500165352026-10-31
00763000774189MSB CD HORIZON Spinal System557500165402026-10-31
00763000774196MSB CD HORIZON Spinal System557500165452026-10-31
00763000774202MSB CD HORIZON Spinal System557500165502026-10-31
00763000774226MSB CD HORIZON Spinal System557500175352026-10-31
00763000774240MSB CD HORIZON Spinal System557500175452026-10-31
00763000774257MSB CD HORIZON Spinal System557500175502026-10-31
00763000774301MSB CD HORIZON Spinal System557500185452026-10-31
00763000777418CD HORIZON Spinal System557500455352026-11-01
00763000777517CD HORIZON Spinal System557500465402026-11-01
00763000777524CD HORIZON Spinal System557500465452026-11-01
00763000777692MSB CD HORIZON Spinal System557500155302026-10-31
00763000777739MSB CD HORIZON Spinal System557500155502026-10-31
00824846010746Medtronic Reusable InstrumentsEX90108492026-11-01
00824846010753Medtronic Reusable InstrumentsEX90108502026-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000857783T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-10-25
00763000857851T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-10-11
00763000857950T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-10-11
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMQP2018-04-16
10888857223769CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223776CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223783CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223790CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223868CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223875CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223882CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223899CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223967CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223974CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223981CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857223998CASCADIA™ Interbody SystemVB Spine LLCMQP2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217584CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19