FDA.report

DISCOVERY ELBOW SYSTEM

Primary DI
00880304457768
Brand
DISCOVERY ELBOW SYSTEM
Company
Biomet Orthopedics, LLC
Model
114829
Catalog number
114829
Published
2015-10-24
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

Related Records

Contact Domains

Product Codes

CodeName
JDCPROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Product Code Classifications

CodeDeviceSpecialtyClass
JDCProsthesis, Elbow, Constrained, CementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00880304457768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304457768008803044577688803044577680880304457768

GMDN Terms

TermDefinition
Metal-backed elbow ulna prosthesisA sterile implantable device designed to replace the proximal ulna as part of an elbow joint replacement. The device is typically comprised of metal-backed polyethylene (PE) and its stem is usually coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags

DUNS number
129278169
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

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00887868551673StageOne Select4311964311962026-03-17
00887868551680StageOne Select4311974311972026-03-17
00887868551697StageOne Select4311984311982026-03-17
00887868551703STAGEONE SELECT4311994311992026-03-17
00889024706774Biomet®32-34169232-3416922026-03-12
00889024706781Biomet®32-14815332-1481532026-03-12
00889024706798Biomet®32-14815132-1481512026-03-12
00889024706804Biomet®32-34169732-3416972026-03-12
00889024706811Biomet®32-14814932-1481492026-03-12
00889024706484Vanguard®32-34702132-3470212026-02-27
00880304009615BMP CABLE CUTTER4980104980102020-05-23
00880304387676OPEN END CUTTER4980234980232020-05-23

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Primary DIBrandCompanyProduct codePublished
07613327668896Modular ElbowHowmedica Osteonics Corp.JDC2025-02-24
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07613327627404SOLARHowmedica Osteonics Corp.JDC2023-06-23
07613327627411SOLARHowmedica Osteonics Corp.JDC2023-06-23
07613327627428SOLARHowmedica Osteonics Corp.JDC2023-06-23
07613327627435SOLARHowmedica Osteonics Corp.JDC2023-06-23
07613327627244SOLARHowmedica Osteonics Corp.JDC2023-06-05
07613327627251SOLARHowmedica Osteonics Corp.JDC2023-06-05
20801902194644ARROWTELEFLEX INCORPORATEDJDC2022-11-08
00887868504051Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2022-04-23
00887868504075Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2022-04-23
00887868504099Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2022-04-23
00887868504174Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2022-04-23
00887868504181Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2022-04-23
00887868504198Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2022-04-23
00887868504228Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2022-04-23
00846832012466Latitude™ - ElbowTORNIER, INC.JDC2022-03-31
37613327590051Axel Pin Assembly Standard ElbowHowmedica Osteonics Corp.JDC2022-03-23
37613327590075Bearing and Axle Bushing Assembly - Standard ElbowHowmedica Osteonics Corp.JDC2022-03-23
00889024639751NAZimmer, Inc.JDC2022-02-25
00889024639768NAZimmer, Inc.JDC2022-02-25
00889024639775NAZimmer, Inc.JDC2022-02-25
00889024639782NAZimmer, Inc.JDC2022-02-25
00889024639799NAZimmer, Inc.JDC2022-02-25
00889024639805NAZimmer, Inc.JDC2022-02-25
00889024466296Nexel®Zimmer, Inc.JDC2022-02-25
00887868543708Comprehensive® SRSBiomet Orthopedics, LLCJDC2021-11-21
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00887868503436Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2021-11-05