FDA.reportPublic FDA data

Cortium Universal OCT Spinal Fixation System

Primary DI
00814386029933
Brand
Cortium Universal OCT Spinal Fixation System
Company
Ulrich Medical Usa, Inc.
Model
UU072-20-0106
Device description
Retaining Sleeve, SR15
Published
2024-11-08
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
NKGPosterior Cervical Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230614000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230614000Cortium™Ulrich Medical USA2023-05-02NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814386029933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814386029933008143860299338143860299330814386029933

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
636-519-0268info@ulrichmedicalusa.com

Regulatory Flags#

DUNS number
624083866
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810076335322MomentumUU062-94-01002026-09-25
00810076338286Cortium NavigationUU076-11-00302026-05-30
00810076338293Cortium NavigationUU076-11-00352026-05-30
00810076338309Cortium NavigationUU076-11-00402026-05-30
00810076338316Cortium NavigationUU076-21-00102026-05-30
00810076338323Cortium NavigationUU076-21-00202026-05-30
00810076338361Cortium NavigationUU076-15-00242026-05-30
00810076338385Cortium NavigationUU076-15-00302026-05-30
00810076338392Cortium NavigationUU076-15-00312026-05-30
00810076338415Cortium NavigationUU076-20-11012026-05-30
00810076338422Cortium NavigationUU076-20-12012026-05-30
00810076338446Cortium NavigationUU073-76-002026-05-30
00810076338552Cortium NavigationUU076-14-01072026-05-30
00810076339443Cortium NavigationUU076-20-21012026-05-30
00810076339450Cortium NavigationUU076-20-22012026-05-30
00810076338330Cortium Universal OCT Spinal Fixation SystemUU072-40-01252026-05-15
00810076338125Momentum UU052-16-01002026-05-08
00810076338132Momentum UU052-16-02002026-05-08
00810076338408uNion MAXUU202-03-00062026-04-30
00810076338347Momentum UU051-10-45252026-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800322693100VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693117VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693124VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693131VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693148VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693155VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693162VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693179VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693186VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693193VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693209VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693216VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693223VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693230VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693247VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693254VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693261VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693278VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693285VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693292VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693308VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693315VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693322VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693339VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693346VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693353VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693360VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693377VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693384VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30
08800322693391VEGA Cervical Screw SystemGS Medical Co., Ltd.NKG2026-09-30