FDA.reportPublic FDA data

NA

Primary DI
00889024035546
Brand
NA
Company
Zimmer, Inc.
Model
1191-48
Catalog number
00-1191-048-00
Published
2017-09-26
Public version status
Update
Distribution status
Not 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
JDQCERCLAGE, FIXATION
LRNWire, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDQCerclage, FixationOrthopedic2
LRNWire, SurgicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150889000Suture Wires and Wire LoopsZimmer, Inc.2015-07-01JDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024035546PrimaryGS10
00889024409835Unit of UseGS10
70889024035545Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024035546008890240355468890240355460889024035546
00889024409835008890244098358890244098350889024409835
7088902403554570889024035545

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length24Inch

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
6
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00889024711464Comp Mini Humeral Tray Trial Stem AdapterSSI008664SSI0086642026-08-25
008890247114712.9 JuggerKnot Self-Punching ObturatorSSI008672SSI0086722026-08-25
008890247114882.9 JuggerKnot Self-Punching CannulaSSI008671SSI0086712026-08-25
00889024712294Pin Target AssemblySSI001470SSI0014702026-08-25
00889024712300Z1 POSTERIOR HAMMR ADPTRSSI008666SSI0086662026-08-25
00889024712317Z1 ANTERIOR HAMMR ADPTRSSI008665SSI0086652026-08-25
00889024712843PTH SHELL PSTNR ASSYSSI008611SSI0086112026-08-25
00889024712850PTH SHELL ADPTR SMLLSSI008612SSI0086122026-08-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982520502STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520519STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520526STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520533STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520540STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520557STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520564STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00193982520571STRETTOGLOBUS MEDICAL, INC.JDQ2026-08-14
00888867525924Arthrex®ARTHREX, INC.JDQ2025-10-20
00888867525931Arthrex®ARTHREX, INC.JDQ2025-10-20
07899258600161Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-15
07899258600598Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-15
07899258600574Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-12
07899258600604Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-12
07899258600611Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-12
07899258600628Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-12
07899258600635Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-12
00850051329038Sternalock EZJACE MEDICAL, LLCJDQ2023-05-26
20705034764051NASynthes GmbHLRN2019-08-29
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00888867026599Arthrex®ARTHREX, INC.JDQ2017-02-15
00898142001357SuperCable® Iso-Elastic™ Cerclage SystemKinamed, Inc.JDQ2015-11-04
00898142001975SuperCable® Iso-Elastic™ Cerclage SystemKinamed, Inc.JDQ2015-11-04
10888857018143CASPIAN® Spinal SystemVB Spine LLCJDQ2015-09-30
10888857083844NILE™ Spinal SystemVB Spine LLCJDQ2015-09-30
10888857083837NILE™ Spinal SystemVB Spine LLCJDQ2015-09-24
04546540568083Dall-MilesHowmedica Osteonics Corp.JDQ2015-09-24
04546540568083Dall-MilesHowmedica Osteonics Corp.LRN2015-09-24
04546540568090Dall-MilesHowmedica Osteonics Corp.JDQ2015-09-24
04546540568090Dall-MilesHowmedica Osteonics Corp.LRN2015-09-24