FDA.reportPublic FDA data

Momentum

Primary DI
00810076339559
Brand
Momentum
Company
Ulrich Medical Usa, Inc.
Model
UU051-11-4550
Device description
Reduction screw, polyaxial, Ø 4.5mm, length 50mm, cannulated
Published
2026-03-20
Public version status
New
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
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191932000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191932000Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA2019-10-02NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810076339559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810076339559008100763395598100763395590810076339559

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended 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 (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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
00810076335322MomentumUU062-94-01002026-09-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197157122522ZAVATION SCREWZavation LLCNKB2026-10-19
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00197157122546ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122553ZAVATION SCREWZavation LLCNKB2026-10-19
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00197157122577ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122584ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122591ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122607ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122614ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122621ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122638ZAVATION SCREWZavation LLCNKB2026-10-19
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00197157122652ZAVATION SCREWZavation LLCNKB2026-10-19
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00197157122683ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122690ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122706ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122713ZAVATION SCREWZavation LLCNKB2026-10-19
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00197157122775ZAVATION SCREWZavation LLCNKB2026-10-19
00197157122782ZAVATION SCREWZavation LLCNKB2026-10-19
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00197157122805ZAVATION SCREWZavation LLCNKB2026-10-19