FDA.reportPublic FDA data

Cortium Universal OCT Spinal Fixation System

Primary DI
00810076338330
Brand
Cortium Universal OCT Spinal Fixation System
Company
Ulrich Medical Usa, Inc.
Model
UU072-40-0125
Device description
Rod Holder, Ratcheting
Published
2026-05-15
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
00810076338330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810076338330008100763383308100763383300810076338330

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. 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
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
00810076339467Momentum UU051-10-45352026-03-20
00810076339474Momentum UU051-10-45402026-03-20
00810076339481Momentum UU051-10-45452026-03-20
00810076339498Momentum UU051-10-45502026-03-20
00810076339504Momentum UU051-11-45252026-03-20
00810076339511Momentum UU051-11-45302026-03-20
00810076339528Momentum UU051-11-45352026-03-20
00810076339535Momentum UU051-11-45402026-03-20
00810076339542Momentum UU051-11-45452026-03-20
00810076339559Momentum UU051-11-45502026-03-20
00810076338545Momentum MIS - Modified InstrumentUU994-96-012026-03-02
00814386029902Momentum UU052-50-00322026-03-02
00810076338217Cortium Universal OCT Spinal Fixation SystemUU994-95-412024-06-19
00810076338224Cortium Universal OCT Spinal Fixation SystemUU994-95-422024-06-19
00814386029971uNion Cervical Plate SystemUU994-47-02UU994-47-022025-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630345705860M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705877M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705884M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705891M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705907M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705914M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705921M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705938M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705945M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705952M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630971299559M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-30
07630971299566M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-30
07630971299573M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-30
07630971299580M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-30
07630971299597M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-30
07630971299528M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-25
07630971299535M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-25
07630971299542M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-25
07630971299368M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299375M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299382M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299399M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299405M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299412M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299429M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299436M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299443M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299450M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299467M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299474M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19