FDA.reportPublic FDA data

DISCOVERY ELBOW SYSTEM

Primary DI
00880304469365
Brand
DISCOVERY ELBOW SYSTEM
Company
Biomet Orthopedics, LLC
Model
114991
Catalog number
114991
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

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304469365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304469365008803044693658803044693650880304469365

GMDN Terms#

Term, Definition table
TermDefinition
Hinged total elbow prosthesisA sterile implantable artificial substitute for an elbow joint designed to replace the articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes humeral and ulnar components, typically with parts made of metal and polyethylene (PE), that form a hinge at articulation. The device may include fixation devices (e.g., screws) for implantation and may be implanted with or without bone cement.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024706828Mini Baseplate Sizer Cannulated HandleSSI008562SSI0085622026-03-19
00889024706835Mini Baseplate Sizer 0 degree On-axis HandleSSI008561SSI0085612026-03-19
00887868551611StageOne Select4311904311902026-03-17
00887868551628StageOne Select4311914311912026-03-17
00887868551635StageOne Select4311924311922026-03-17
00887868551642StageOne Select4311934311932026-03-17
00887868551659StageOne Select4311944311942026-03-17
00887868551666StageOne Select4311954311952026-03-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327668896Modular ElbowHowmedica Osteonics Corp.JDC2025-02-24
00889024649637Nexel®Zimmer, Inc.JDC2024-08-16
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
00887868503375Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2021-11-05
00887868503412Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2021-11-05
00887868503436Comprehensive® SRS InstrumentBiomet Orthopedics, LLCJDC2021-11-05