FDA.reportPublic FDA data

Cortium Universal OCT Spinal Fixation System

Primary DI
00810076338378
Brand
Cortium Universal OCT Spinal Fixation System
Company
Ulrich Medical Usa, Inc.
Model
UU072-40-0065
Device description
Axial Rod Reducer
Published
2025-04-18
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
00810076338378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810076338378008100763383788100763383780810076338378

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic rod reducerA heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. 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