FDA.reportPublic FDA data

Cortium Universal OCT Spinal Fixation System

Primary DI
00814386029964
Brand
Cortium Universal OCT Spinal Fixation System
Company
Ulrich Medical Usa, Inc.
Model
UU072-20-0108
Device description
Tissue Sleeve, SR15 Driver
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
00814386029964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814386029964008143860299648143860299640814386029964

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. 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
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
00810076338354Momentum UU051-10-45302026-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982521134QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521141QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521158QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521165QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521172QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521189QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521196QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521202QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521219QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521226QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521233QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521240QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521257QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521264QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521271QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00889095368611QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00889095368628QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00889095368635QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00889095368642QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00840606193382Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193399Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193405Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193412Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193429Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193436Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193443Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193450Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194044Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194051Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194068Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30