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

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
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
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
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