FDA.reportPublic FDA data

Mini Magna-Fx®

Primary DI
00889024024809
Brand
Mini Magna-Fx®
Company
Zimmer, Inc.
Model
1142-18
Catalog number
00-1142-018-00
Published
2017-09-14
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
NDGWASHER, BOLT, NUT, NON-SPINAL, METALLIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDGWasher, Bolt, Nut, Non-Spinal, MetallicOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142442000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142442000MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEMZimmer, Inc.2014-10-03HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024024809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024024809008890240248098890240248090889024024809

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone washer, non-sterileA non-sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024699854IDENTITY Humeral1200017901200017902026-10-21
00889024699861IDENTITY Humeral1200017911200017912026-10-21
00889024699878IDENTITY Humeral1200017921200017922026-10-21
00889024699885IDENTITY Humeral1200017931200017932026-10-21
00889024699892IDENTITY Humeral1200017941200017942026-10-21
00889024699908IDENTITY Humeral1200017951200017952026-10-21
00889024699915Comprehensive Humeral1200017981200017982026-10-21
00889024699922Identity Humeral1200017991200017992026-10-21
00889024699939N/A1200020041200020042026-10-20
00889024699946N/A1200020051200020052026-10-20
00889024699953Alliance Glenoid, Identity Humeral1200060141200060142026-10-20
00889024709164CANNULATED 1.5MM HEX DRIVERSSI004137SSI0041372026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERSSI004138SSI0041382026-10-19
00889024715196T6 Driver 127mm AO QCSSI008712SSI0087122026-10-19
00889024715202T8 Driver 127mm AO QCSSI008713SSI0087132026-10-19
00889024715295Persona Extended V/V Guide Assembly (MFS)SSI008760SSI0087602026-10-19
00889024715271Affixus®2113060432113060432026-10-06
00889024707160G7® Vivacit-E®30104005301040052026-09-30
00889024707184G7® Vivacit-E®30103603301036032026-09-30
00889024707207G7® Vivacit-E®30104407301044072026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998470431Solventum™ Bair Hugger™Solventum US LLCNDG2026-04-29
00197998470455Solventum™ Bair Hugger™Solventum US LLCNDG2026-04-29
08800089451005Summa Orthopaedics System Bone ScrewJeil Medical CorporationNDG2024-09-25
08800089446643ARIX System Bone ScrewJeil Medical CorporationNDG2024-03-19
00842188125362WashersTrimed, INC.NDG2023-01-05
05055662967555Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDNDG2022-05-25
00810028392106Arsenal AnkleTrilliant Surgical, LLCNDG2022-05-02
00810028392113Arsenal AnkleTrilliant Surgical, LLCNDG2022-05-02
08800089420391INLET System Bone ScrewJeil Medical CorporationNDG2021-11-19
08800089420407INLET System Bone ScrewJeil Medical CorporationNDG2021-11-19
05055662964844Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDNDG2021-06-25
00885556784006EVOSSmith & Nephew, Inc.NDG2021-05-11
00885556784013EVOSSmith & Nephew, Inc.NDG2021-05-11
00885556784020EVOSSmith & Nephew, Inc.NDG2021-05-11
00885556784037EVOSSmith & Nephew, Inc.NDG2021-05-11
20885556746022SMART TSFSmith & Nephew, Inc.NDG2020-11-03
00885556746028SMART TSFSmith & Nephew, Inc.NDG2020-11-03
00885556746035SMART TSFSmith & Nephew, Inc.NDG2020-11-03
08806390891912Prometheus System Bone ScrewJeil Medical CorporationNDG2020-09-01
08806390891929Prometheus System Bone ScrewJeil Medical CorporationNDG2020-09-01
08806390891936Prometheus System Bone ScrewJeil Medical CorporationNDG2020-09-01
08806390858014VERUM System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390858021VERUM System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390865821Summa Orthopaedics System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390865838Summa Orthopaedics System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390883641Summa Orthopaedics System Bone ScrewJeil Medical CorporationNDG2020-02-18
08806390850742ARIX System Bone ScrewJeil Medical CorporationNDG2019-12-12
08806390862288ARIX System Bone ScrewJeil Medical CorporationNDG2019-12-12
08809282815508ARIX System Bone ScrewJeil Medical CorporationNDG2019-12-12
08809282815515ARIX System Bone ScrewJeil Medical CorporationNDG2019-12-12