FDA.reportPublic FDA data

Nexel®

Primary DI
00889024649637
Brand
Nexel®
Company
Zimmer, Inc.
Model
00-8401-056-20
Catalog number
00-8401-056-20
Published
2024-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDCPROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDCProsthesis, Elbow, Constrained, CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123862000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123862000ZIMMER NEXEL TOTAL ELBOWZimmer, Inc.2013-03-12JDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024649637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024649637008890246496378890246496370889024649637

GMDN Terms#

Term, Definition table
TermDefinition
Elbow humerus prosthesis trialA copy of a final humerus prosthesis designed to be used for trial reductions during elbow arthroplasty to judge the correct size, length, condyle positioning, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
056038268
Device count
1
Lot or batch
true
Manufacturing date on label
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
10801902194029ARROWTELEFLEX INCORPORATEDJDC2026-08-01
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
10801902194647ARROWTELEFLEX INCORPORATEDJDC2022-11-08
00846832012459Latitude™ - ElbowTORNIER, INC.JDC2022-03-31
00846832012473Latitude™ - ElbowTORNIER, INC.JDC2022-03-31
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