FDA.reportPublic FDA data

L2L®

Primary DI
00889024581968
Brand
L2L®
Company
Zimmer, Inc.
Model
00-8700-001-24
Catalog number
00-8700-001-24
Published
2019-10-21
Public version status
New
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
KWIPROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWIProsthesis, Elbow, Hemi-, Radial, PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024581968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024581968008890245819688890245819680889024581968

GMDN Terms#

Term, Definition table
TermDefinition
Elbow radius prosthesisA sterile implantable device designed to replace the proximal radius typically as treatment for severe radial head fracture or degenerative disease (arthritis). The device includes a radial head or radial head with stem and is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] or metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed 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)348-2759zimmer.consumerrelations@zimmerbiomet.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
00887868150876Affixus®8151113008151113002026-03-20
00887868150333Affixus®8151103008151103002026-03-19
00887868150340Affixus®8151103208151103202026-03-19
00887868150357Affixus®8151103408151103402026-03-19
00887868150364Affixus®8151103608151103602026-03-19
00887868150371Affixus®8151103808151103802026-03-19
00887868150388Affixus®8151104008151104002026-03-19
00887868150395Affixus®8151104208151104202026-03-19
00887868150401Affixus®8151114208151114202026-03-19
00887868150555Affixus®8151123008151123002026-03-19
00887868150562Affixus®8151123208151123202026-03-19
00887868150579Affixus®8151123408151123402026-03-19
00887868150586Affixus®8151123608151123602026-03-19
00887868150593Affixus®8151123808151123802026-03-19
00887868150609Affixus®8151124008151124002026-03-19
00887868150616Affixus®8151124208151124202026-03-19
00887868150883Affixus®8151113208151113202026-03-19
00887868150890Affixus®8151113408151113402026-03-19
00887868150906Affixus®8151113608151113602026-03-19
00887868150913Affixus®8151113808151113802026-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841506148953AlignSKELETAL DYNAMICS L.L.C.KWI2025-12-01
00841506148960AlignSKELETAL DYNAMICS L.L.C.KWI2025-12-01
00850005618034BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618041BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618058BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618065BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618072BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618089BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618249BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618256BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618263BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618287BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618294BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618461BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618478BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618485BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618492BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618508BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618522BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618539 BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618546BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618553BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618560BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618577BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618584BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618591BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618607BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618614BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618621BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618638BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02