FDA.reportPublic FDA data

Spetzler Neuro Patties

Primary DI
M731K91069
Brand
Spetzler Neuro Patties
Company
OMT, LLC
Model
K Series
Catalog number
K-9106
Device description
"Neuro Pattie; 1/8"" [W] x 2-1/2"" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
Published
2025-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBANeurosurgical Paddie

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBANeurosurgical PaddieNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020736000TRAATEK COTTONOID PATTIESTraatek, Inc.2002-06-03HBA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M731K91069PrimaryHIBCC0
9106200Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cottonoid padA cushion-like mass made of cotton or man-made fibres used during surgery (e.g., neurosurgery) to protect tissue, absorb fluids, and/or stop bleeding. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature30 Degrees Fahrenheit70 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
954-327-5687regulatory@omtmedical.com

Regulatory Flags#

DUNS number
196899772
Device count
200
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M731K90019Spetzler Neuro PattiesK SeriesK-90012025-12-31
M731K90049Spetzler Neuro PattiesK SeriesK-90042025-12-31
M731K90059Spetzler Neuro PattiesK SeriesK-90052025-12-31
M731K90069Spetzler Neuro PattiesK SeriesK-90062025-12-31
M731K90079Spetzler Neuro PattiesK SeriesK-90072025-12-31
M731K90089Spetzler Neuro PattiesK SeriesK-90082025-12-31
M731K90099Spetzler Neuro PattiesK SeriesK-90092025-12-31
M731K90109Spetzler Neuro PattiesK SeriesK-90102025-12-31
M731K90159Spetzler Neuro PattiesK SeriesK-90152025-12-31
M731K90169Spetzler Neuro PattiesK SeriesK-90162025-12-31
M731K90179Spetzler Neuro PattiesK SeriesK-90172025-12-31
M731K90189Spetzler Neuro PattiesK SeriesK-90182025-12-31
M731K90199Spetzler Neuro PattiesK SeriesK-90192025-12-31
M731K90209Spetzler Neuro PattiesK SeriesK-90202025-12-31
M731K90219Spetzler Neuro PattiesK SeriesK-90212025-12-31
M731K90229Spetzler Neuro PattiesK SeriesK-90222025-12-31
M731K90239Spetzler Neuro PattiesK SeriesK-90232025-12-31
M731K90269Spetzler Neuro PattiesK SeriesK-90262025-12-31
M731K90279Spetzler Neuro PattiesK SeriesK-90272025-12-31
M731K90289Spetzler Neuro PattiesK SeriesK-90282025-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000663292ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663308ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663346ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663353ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663360ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
00763000663735ZEVO™ Anterior Cervical Plate SystemMEDTRONIC SOFAMOR DANEK, INC.HBA2026-03-19
M731K90019Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90049Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90059Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90069Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90079Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90089Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90099Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90109Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90159Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90169Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90179Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90189Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90199Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90209Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90219Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90229Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90239Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90269Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90279Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90289Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90299Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90509Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90519Spetzler Neuro PattiesOMT, LLCHBA2025-12-31
M731K90529Spetzler Neuro PattiesOMT, LLCHBA2025-12-31