FDA.reportPublic FDA data

OptiMesh 1500 S

Primary DI
M7403002702
Brand
OptiMesh 1500 S
Company
SPINEOLOGY INC.
Model
10-10-04-3
Catalog number
300-2702
Device description
Surgical Mesh
Published
2015-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K014200000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K014200000OPTIMESHSpineology, Inc.2003-11-26EZX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7403002702PrimaryHIBCC0

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length27Millimeter

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(651)256-8500jhauge@spineology.com

Regulatory Flags#

DUNS number
033014361
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7401001380OptiLIF Endo, Direct Visualization System102-90-01100-13802026-10-01
M7401001376Threshold Pedicular Fixation System102-88-01100-13762026-08-21
M7401001377Threshold Pedicular Fixation System102-88-02100-13772026-08-21
M7401001378Threshold Pedicular Fixation System102-88-03100-13782026-08-21
M7409200004MIS TLIF System92-02-01920-00042026-08-07
M7403030001Discectomy Set10-01-138303-00012026-07-08
M7403030002Discectomy Set10-01-139303-00022026-07-08
M7403030069Discectomy Set15-01-58303-00692026-07-08
M7403030070Discectomy Set15-01-59303-00702026-07-08
M7403030071Discectomy Set15-01-60303-00712026-07-08
M7404300035CAPTURE Facet Screw Set System70-02-008-1430-00352026-05-29
M7403030028Discectomy Set15-01-45-1303-00282026-05-28
M7403030029Discectomy Set15-01-45-2303-00292026-05-28
M7403030030Discectomy Set15-01-45-3303-00302026-05-28
M7403030031Discectomy Set15-01-45-4303-00312026-05-28
M7403030032Discectomy Set15-01-45-5303-00322026-05-28
M7403030033Discectomy Set15-01-45-6303-00332026-05-28
M7403030034Discectomy Set15-01-45-7303-00342026-05-28
M7403030035Discectomy Set15-01-45-8303-00352026-05-28
M7403030036Discectomy Set15-01-45-9303-00362026-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
00763000856625Pyramesh® 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