FDA.reportPublic FDA data

NA

Primary DI
00889024380424
Brand
NA
Company
Zimmer, Inc.
Model
32-8105-38
Published
2016-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDBPROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDBProsthesis, Elbow, Semi-Constrained, CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040389000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040389000COONRAD/MORREY ELBOW CEMENT RESTRICTORZimmer, Inc.2004-05-17JDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024380424PackageGS132In Commercial Distribution
00889024274082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024380424008890243804248890243804240889024380424
00889024274082008890242740828890242740820889024274082

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter16Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
056038268
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024713505G7® TM Acetabular System1200013321200013322026-11-03
00889024713512G7® TM Acetabular System7574000427574000422026-11-03
00889024713529G7® TM Acetabular System7574000447574000442026-11-03
00889024713536G7® TM Acetabular System7574000467574000462026-11-03
00889024713543G7® TM Acetabular System7574000487574000482026-11-03
00889024713550G7® TM Acetabular System7574000507574000502026-11-03
00889024713567G7® TM Acetabular System7574000527574000522026-11-03
00889024713574G7® TM Acetabular System7574000547574000542026-11-03
00889024713581G7® TM Acetabular System7574000567574000562026-11-03
00889024713598G7® TM Acetabular System7574000587574000582026-11-03
00889024713604G7® TM Acetabular System7574000607574000602026-11-03
00889024713611G7® TM Acetabular System7574000627574000622026-11-03
00889024713628G7® TM Acetabular System7574000647574000642026-11-03
00889024713635G7® TM Acetabular System7574000667574000662026-11-03
00889024713642G7® TM Acetabular System7574000687574000682026-11-03
00889024713659G7® TM Acetabular System7574000707574000702026-11-03
00889024713666G7® TM Acetabular System7574000727574000722026-11-03
00889024713673G7® TM Acetabular System7574000747574000742026-11-03
00889024713680G7® TM Acetabular System7574000767574000762026-11-03
00889024713697G7® TM Acetabular System7574000787574000782026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846832012466Latitude™ - ElbowTORNIER, INC.JDB2022-03-31
93700386926603TEST-SALTO TALARISTORNIERJDB2019-12-23
08033390126465TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390126922TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390128810TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390128827TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390128834TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390128858TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390128889TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138093TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138116TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138130TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138185TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138215TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138239TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138253TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138284TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138307TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138321TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138383TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138437TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138444TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138451TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138468TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138499TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138505TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138529TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138536TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138543TEMA ElbowLIMACORPORATE SPAJDB2019-05-24
08033390138550TEMA ElbowLIMACORPORATE SPAJDB2019-05-24