FDA.reportPublic FDA data

NA

Primary DI
00889024274082
Brand
NA
Company
Zimmer, Inc.
Model
32-8105-38
Catalog number
32-8105-038-00
Published
2016-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDBProsthesis, Elbow, Semi-Constrained, CementedOrthopedic2
JDCProsthesis, Elbow, 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
00889024274082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

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

GMDN Terms#

Term, Definition table
TermDefinition
Polymer orthopaedic cement restrictor, non-bioabsorbable, sterileA sterile, non-bioabsorbable, implantable device designed to be inserted into the medullary canal of a bone (e.g., femur, tibia, or humerus) during orthopaedic surgery to prevent cement progression in the diaphysis and therefore facilitate cement pressurization during the introduction of an implant. It is typically made of polyetheretherketone (PEEK) or ultrahigh molecular weight polyethylene (UHMWPE) and is available in a variety of designs, e.g., straight or tapered, hollow with a fenestrated surface, and it may have a toothed surface to prevent its migration from the desired location. It may incorporate a metal orientation marker for radiographs and is not intended for spinal indication.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter16Millimeter
Outer Diameter25Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
056038268
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024707382Persona Tensor Sizer Arm – LongSSI008513SSI0085132026-05-29
00889024707399Persona Tensor Sizer Arm – StdSSI008567SSI0085672026-05-29
00889024707405Persona Tensor Sizer BodySSI008566SSI0085662026-05-29
00889024081024XtraFix® Large External Fixation System00-5207-024-3000-5207-024-302016-08-09
00889024081055XtraFix® Large External Fixation System00-5207-032-3000-5207-032-302016-07-27
00889024081062XtraFix® Large External Fixation System00-5207-040-1000-5207-040-102016-07-28
00889024081079XtraFix® Large External Fixation System00-5207-040-7000-5207-040-702016-07-28
00889024081086XtraFix® Large External Fixation System00-5207-045-1000-5207-045-102016-07-28
00889024081093XtraFix® Large External Fixation System00-5210-009-0100-5210-009-012016-09-28
00889024081109XtraFix® Large External Fixation System00-5210-009-0200-5210-009-022016-09-28
00889024081147XtraFix® Large External Fixation System00-5210-019-0100-5210-019-012016-09-28
00889024081154XtraFix® Large External Fixation System00-5210-029-0100-5210-029-012016-09-28
00889024081178XtraFix® Large External Fixation System00-5210-040-0000-5210-040-002016-09-28
00889024081185XtraFix® Large External Fixation System00-5210-040-0100-5210-040-012016-09-28
00889024081192XtraFix® Large External Fixation System00-5210-040-0200-5210-040-022016-09-28
00889024081208XtraFix® Large External Fixation System00-5210-040-0300-5210-040-032016-09-28
00889024081215XtraFix® Large External Fixation System00-5210-040-0400-5210-040-042016-09-28
00889024081239XtraFix® Large External Fixation System00-5210-040-0600-5210-040-062016-09-28
00889024081253XtraFix® Large External Fixation System00-5210-050-0100-5210-050-012016-09-28
00889024081260XtraFix® Large External Fixation System00-5210-050-0200-5210-050-022016-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327668889Modular ElbowHowmedica Osteonics Corp.JDC2025-02-24
07613327668902Modular ElbowHowmedica Osteonics Corp.JDC2025-02-24
07613327668919Modular ElbowHowmedica Osteonics Corp.JDC2025-02-24
08033390195225TEMA Elbow System LIMACORPORATE SPAJDC2024-07-26
08033390150934TEMA ElbowLIMACORPORATE SPAJDC2023-03-10
08033390150941TEMA ElbowLIMACORPORATE SPAJDC2023-03-10
08033390173186TEMA ElbowLIMACORPORATE SPAJDC2023-03-10
08033390173230TEMA ElbowLIMACORPORATE SPAJDC2023-03-10
08033390175449TEMA ElbowLIMACORPORATE SPAJDC2023-03-10
08033390175456TEMA ElbowLIMACORPORATE SPAJDC2023-03-10
08033390196802TEMA ElbowLIMACORPORATE SPAJDC2023-02-18
08033390196819TEMA ElbowLIMACORPORATE SPAJDC2023-02-18
08033390196826TEMA ElbowLIMACORPORATE SPAJDC2023-02-18
08033390196833TEMA ElbowLIMACORPORATE SPAJDC2023-02-18
08033390231435TEMA ElbowLIMACORPORATE SPAJDC2023-02-18
08033390231442TEMA ElbowLIMACORPORATE SPAJDC2023-02-18
08033390231459TEMA ElbowLIMACORPORATE SPAJDC2023-02-18
08033390126441TEMA ElbowLIMACORPORATE SPAJDC2023-01-25
07613327590050Axel Pin Assembly Standard ElbowHowmedica Osteonics Corp.JDC2022-03-23
07613327590074Bearing and Axle Bushing Assembly - Standard ElbowHowmedica Osteonics Corp.JDC2022-03-23
08033390151252TEMA Elbow System LIMACORPORATE SPAJDC2021-11-27
08033390151269TEMA Elbow System LIMACORPORATE SPAJDC2021-11-27
08033390151276TEMA Elbow System LIMACORPORATE SPAJDC2021-11-27
08033390151283TEMA Elbow System LIMACORPORATE SPAJDC2021-11-27
08033390151290TEMA Elbow System LIMACORPORATE SPAJDC2021-11-27
08033390151306TEMA Elbow System LIMACORPORATE SPAJDC2021-11-27
08033390151313TEMA Elbow System LIMACORPORATE SPAJDC2021-11-27
08033390151320TEMA Elbow System LIMACORPORATE SPAJDC2021-11-27
08033390128865TEMA ElbowLIMACORPORATE SPAJDC2021-05-11
08033390128872TEMA ElbowLIMACORPORATE SPAJDC2021-05-11