FDA.reportPublic FDA data

uCentum

Primary DI
04052536220755
Brand
uCentum
Company
Ulrich GmbH & Co. KG
Model
CS 3890-032-002
Device description
Layer 2 for uCentum longarm-screws Ø 6.5 mm, perforated
Published
2026-05-19
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
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION
NKBOrthosis, spinal pedicle fixation, for degenerative disc disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123717000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123717000UCENTUMUlrich GmbH & Co. KG2013-03-04NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052536083855PreviousGS10
04052536220755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052536083855040525360838554052536083855
04052536220755040525362207554052536220755

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4973196540safety@ulrichmedical.com

Regulatory Flags#

DUNS number
315494757
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04052536078349neon3CS 71502026-06-09
04052536078356neon3CS 71522026-06-09
04052536078363neon3CS 71542026-06-09
04052536123728mamboCS 71342026-06-09
04052536163403neon3CS 3994-002-0002026-06-09
04052536163410neon3CS 3994-001-0002026-06-09
04052536163434neon3CS 3994-003-0002026-06-09
04052536164585neon3CS 3994-001-0012026-06-09
04052536164592neon3CS 3994-001-0022026-06-09
04052536164608neon3CS 3994-001-0032026-06-09
04052536169931neon3CS 71552026-06-09
04052536177516neon3CS 7040-652026-06-09
04052536218073uCentumUL 8526-232026-06-09
04052536218080uCentumUL 8527-232026-06-09
04052536221202uCentumCS 7020-62026-06-09
04052536221219uCentumCS 7040-42026-06-09
04052536221233uCentumCS 7040-62026-06-09
04052536085651neon3CS 39412026-06-08
04052536085668neon3CS 39422026-06-08
04052536161997neon3CS 3940-012026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-06-28
10889981441555VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981005115NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005115NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005115NewportSeaspine Orthopedics CorporationNKB2015-09-24
10889981005139NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005139NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005139NewportSeaspine Orthopedics CorporationNKB2015-09-24
10889981005146NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005146NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005146NewportSeaspine Orthopedics CorporationNKB2015-09-24
10889981005290NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005290NewportSeaspine Orthopedics CorporationNKB2015-09-24
10889981005290NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005306NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005306NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005306NewportSeaspine Orthopedics CorporationNKB2015-09-24
10889981005313NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005313NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005313NewportSeaspine Orthopedics CorporationNKB2015-09-24
10889981005320NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005320NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005320NewportSeaspine Orthopedics CorporationNKB2015-09-24
10889981005337NewportSeaspine Orthopedics CorporationNKB2015-09-24