FDA.reportPublic FDA data

Cortium Universal OCT Spinal Fixation System

Primary DI
00814386026130
Brand
Cortium Universal OCT Spinal Fixation System
Company
Ulrich Medical Usa, Inc.
Model
UU071-00-3534
Device description
Smooth shank screw, Ø 3.5mm, length 34mm, high angulation
Published
2024-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
00814386026130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814386026130008143860261308143860261300814386026130

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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
04052536162109neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162123neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162185neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162192neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162208neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536194285neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536194292neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536194308neon3Ulrich GmbH & Co. KGNKG2026-06-08
00840283403897VySpan™VY SPINE LLCNKG2026-06-05
00840283403927VySpan™VY SPINE LLCNKG2026-06-05
04052536085491neon3Ulrich GmbH & Co. KGNKG2026-05-28
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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
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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