FDA.reportPublic FDA data

NA

Primary DI
00889024038035
Brand
NA
Company
Zimmer, Inc.
Model
1292-60
Catalog number
00-1292-060-00
Published
2015-09-24
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
JDQCERCLAGE, FIXATION
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDQCerclage, FixationOrthopedic2
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150889000
K913561000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150889000Suture Wires and Wire LoopsZimmer, Inc.2015-07-01JDQ
K913561000LUQUE SEGMENTAL SPINAL INSTRUMENTATIONZimmer, Inc.1992-01-16KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024038035PrimaryGS10
00889024409842Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024038035008890240380358890240380350889024038035
00889024409842008890244098428890244098420889024409842

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
Length20Centimeter

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
10
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00889024712867PTH SHELL ADPTR LRGSSI008658SSI0086582026-08-25
00889024712874PTH BOOMSSI008680SSI0086802026-08-25
00889024712881PTH TROCARSSI008681SSI0086812026-08-25
008890247128986.5/8.0mm Countersink, Cannulated ZH QCSSI008697SSI0086972026-08-25
00889024712904RMR LONG KEYSSI008690SSI0086902026-08-25
00889024712911X BAR RMR ADPT TALLSSI008688SSI0086882026-08-25
00889024712928RMR SHORT KEYSSI008689SSI0086892026-08-25
00889024712935RMR SHORT KEY BENTSSI008691SSI0086912026-08-25
00889024712942RMR LONG KEY BENTSSI008692SSI0086922026-08-25
00889024713277Universal Uni Knee TensorSSI008695SSI0086952026-08-25
00889024713284Right Uni Knee TensorSSI008696SSI0086962026-08-25
00889024713291Left Uni Knee TensorSSI008694SSI0086942026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857037953EVEREST® Spinal SystemVB Spine LLCKWP2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCKWP2026-06-11
10888857001428DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857046733MESA® Small Stature Spinal SystemVB Spine LLCKWP2016-09-02
10888857008724EVEREST® Spinal SystemVB Spine LLCKWP2016-03-10
10888857001497DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001640DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001725DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001763DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001787DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001824DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001848DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001923DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001947DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001978DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001992DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857002036DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857002050DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857002074DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857002098DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24