FDA.reportPublic FDA data

Omnia Medical PSiFDNA

Primary DI
00843511122799
Brand
Omnia Medical PSiFDNA
Company
OMNIA MEDICAL, LLC
Model
11-5P-DRL1-SS
Catalog number
11-5P-DRL1-SS
Device description
PsiF DNA Drill
Published
2025-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242431000Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC2025-06-06OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843511122799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843511122799008435111227998435111227990843511122799

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
3044164851customerservice@omniamedical.com

Regulatory Flags#

DUNS number
079467378
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843511128777Omnia Medical TiBrid™-A/SA14-5A-QAT114-5A-QAT12026-06-01
00843511128388Omnia Medical TiBrid™- A/SA 17-5A-BL0617-5A-BL062026-05-11
00843511128395Omnia Medical TiBrid™- A/SA 17-5A-BL082026-05-11
00843511128401Omnia Medical TiBrid™- A/SA 17-5A-BL102026-05-11
00843511128418Omnia Medical TiBrid™- A/SA 17-5A-BL122026-05-11
00843511128425Omnia Medical TiBrid™- A/SA 17-5A-BL142026-05-11
00843511128432Omnia Medical TiBrid™- A/SA 17-5A-BL162026-05-11
00843511128463Omnia Medical TiBrid™- A/SA 17-5A-AWL1-B2026-05-11
00843511128494Omnia Medical TiBrid™-C07-5C-LTDE2026-05-11
00843511128500Omnia Medical Instruments99-5A-CL132026-05-11
00843511128517Omnia Medical Instruments99-5A-CL202026-05-11
00843511128548Omnia Medical Golden Spike OM-TLS4015-T2026-05-11
00843511128555Omnia Medical Golden Spike OM-TLS4016-T2026-05-11
00843511128562Omnia Medical Golden Spike OM-TLS4017-T2026-05-11
00843511128579Omnia Medical Golden Spike OM-TLS4018-T2026-05-11
00843511128586Omnia Medical Golden Spike OM-TLS4019-T2026-05-11
00843511128593Omnia Medical Golden Spike OM-TLS4020-T2026-05-11
00843511128609Omnia Medical Golden Spike OM-TLS4021-T2026-05-11
00843511128616Omnia Medical Golden Spike OM-TLS4022-T2026-05-11
00843511128623Omnia Medical Golden Spike OM-TLS4023-T2026-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327075830ASNISStryker GmbHOUR2015-11-11
07613327076189ASNISStryker GmbHOUR2015-11-11
07613327076301ASNISStryker GmbHOUR2015-11-11
07613327076554ASNISStryker GmbHOUR2015-11-11
07613327076721ASNISStryker GmbHOUR2015-11-11
07613327076929ASNISStryker GmbHOUR2015-11-11
07613327077049ASNISStryker GmbHOUR2015-11-11
07613327077308ASNISStryker GmbHOUR2015-11-11
07613327077315ASNISStryker GmbHOUR2015-11-11
07613327077346ASNISStryker GmbHOUR2015-11-11
07613327077391ASNISStryker GmbHOUR2015-11-11
07613327077414ASNISStryker GmbHOUR2015-11-11
07613327077483ASNISStryker GmbHOUR2015-11-11
07613327077513ASNISStryker GmbHOUR2015-11-11
07613327077544ASNISStryker GmbHOUR2015-11-11
07613327077582ASNISStryker GmbHOUR2015-11-11
07613327077605ASNISStryker GmbHOUR2015-11-11
07613327077612ASNISStryker GmbHOUR2015-11-11
07613327077643ASNISStryker GmbHOUR2015-11-11
07613327077674ASNISStryker GmbHOUR2015-11-11
07613327077704ASNISStryker GmbHOUR2015-11-11
07613327077735ASNISStryker GmbHOUR2015-11-11
07613154158980NAStryker GmbHOUR2015-09-24
07613252232674ASNISStryker GmbHOUR2015-09-24
07613252232681ASNISStryker GmbHOUR2015-09-24
07613252232698ASNISStryker GmbHOUR2015-09-24
07613252232704ASNISStryker GmbHOUR2015-09-24
07613252232711ASNISStryker GmbHOUR2015-09-24
07613252232728ASNISStryker GmbHOUR2015-09-24
07613252232735ASNISStryker GmbHOUR2015-09-24