FDA.reportPublic FDA data

DISCOVERY ELBOW SYSTEM

Primary DI
00880304215740
Brand
DISCOVERY ELBOW SYSTEM
Company
Biomet Orthopedics, LLC
Model
114901
Catalog number
114901
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
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304215740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304215740008803042157408803042157400880304215740

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08033390272797SMR SystemLIMACORPORATE SPAKWT2026-02-25
08033390272803SMR SystemLIMACORPORATE SPAKWT2026-02-25
08033390272810SMR SystemLIMACORPORATE SPAKWT2026-02-25
10885862657046CSBExactech, Inc.KWT2026-01-28
10885862657053CSBExactech, Inc.KWT2026-01-28
B1132L1S0400020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S0600020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S0600030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S0800020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S0800030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S1000020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S1000030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S1200020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S1200030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.KWT2025-12-12
B1132L2HB000020Shoulder Innovations InSet 135 Instrument Case/TrayShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB000030Shoulder Innovations InSet 185 Instrument Case/TrayShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB235040Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB235060Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB235080Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB235100Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB235120Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB285060Shoulder Innovations InSet FxR 185 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB285080Shoulder Innovations InSet FxR 185 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB285100Shoulder Innovations InSet FxR 185 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB285120Shoulder Innovations InSet FxR 185 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HI135010Shoulder Innovations InSet 135 Impaction Stand TowerShoulder Innovations, Inc.KWT2025-12-12
B1132L2HI135020Shoulder Innovations InSet 135/185 Impaction Stand BaseShoulder Innovations, Inc.KWT2025-12-12
B1132L2HI135030Shoulder Innovations InSet 135/185 Adjustable FootShoulder Innovations, Inc.KWT2025-12-12