FDA.reportPublic FDA data

uNion MAX

Primary DI
00810076337296
Brand
uNion MAX
Company
Ulrich Medical Usa, Inc.
Model
UU201-42-4022
Device description
Screw, Ø4.0 x 22mm, Self-Drilling/Self-Tapping Teal, Fixed
Published
2024-08-05
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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240515000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240515000uNion® MAX Cervical Plate SystemUlrich Medical USA, Inc.2024-03-18KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810076337296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810076337296008100763372968100763372960810076337296

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840354204958Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204965Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204972Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204989Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204996Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205009Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205016Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205023Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205030Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205047Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205054Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205061Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205078Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205085Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205092Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205108Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205115Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205122Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205139Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205146Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205153Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205160Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205177Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205184Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205191Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205207Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354203654Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203661Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203678Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203685Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06