FDA.reportPublic FDA data

NA

Primary DI
00889024115125
Brand
NA
Company
Zimmer, Inc.
Model
4555-07
Published
2016-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDDPROSTHESIS, UPPER FEMORAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDDProsthesis, Upper FemoralOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024115125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024115125008890241151258890241151250889024115125

GMDN Terms#

Term, Definition table
TermDefinition
Femoral head/stem prosthesis adaptorA sterile implantable tubular device designed to connect a femoral head prosthesis to the trunnion of a femoral stem prosthesis. It is typically intended to be used as part of a total hip arthroplasty (THA) revision to correct offset, neck length, lateralization, and anteversion/retroversion where there is a good fitting stem; it may also be used as part of a primary procedure. It is made of metal [e.g., titanium (Ti) alloy] and is available in various sizes and shapes; it is intended to be used with a dedicated femoral head prosthesis.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
056038268
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024710580Custom Femoral Lateralizing ReamerSSI008673SSI0086732026-07-20
00889024711495Z1 ExtractorSSI008663SSI0086632026-07-20
00889024701281Identity® Shoulder System11007733110077332026-06-10
00889024701298Identity® Shoulder System11007734110077342026-06-10
00889024701304Identity® Shoulder System11007735110077352026-06-10
00889024701311Identity® Shoulder System11007736110077362026-06-10
00889024701328Identity® Shoulder System11007737110077372026-06-10
00889024701335Identity® Shoulder System11007738110077382026-06-10
00889024701342Identity® Shoulder System11007739110077392026-06-10
00889024701359Identity® Shoulder System11007740110077402026-06-10
00889024701366Identity® Shoulder System11007741110077412026-06-10
00889024701373Identity® Shoulder System11007742110077422026-06-10
00889024701380Identity® Shoulder System11007743110077432026-06-10
00889024701397Identity® Shoulder System11007744110077442026-06-10
00889024701403Identity® Shoulder System11007745110077452026-06-10
00889024701410Identity® Shoulder System11007746110077462026-06-10
00889024701427Identity® Shoulder System11007747110077472026-06-10
00889024701434Identity® Shoulder System11007748110077482026-06-10
00889024701441Identity® Shoulder System11007749110077492026-06-10
00889024701458Identity® Shoulder System11007750110077502026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03596010377135NASmith & Nephew, Inc.JDD2015-08-29
03596010377142NASmith & Nephew, Inc.JDD2015-08-29
03596010377159NASmith & Nephew, Inc.JDD2015-08-29
03596010377166NASmith & Nephew, Inc.JDD2015-08-29
03596010377173NASmith & Nephew, Inc.JDD2015-08-29
03596010377180NASmith & Nephew, Inc.JDD2015-08-29
03596010377197NASmith & Nephew, Inc.JDD2015-08-29
03596010377203NASmith & Nephew, Inc.JDD2015-08-29
03596010377210NASmith & Nephew, Inc.JDD2015-08-29
03596010377227NASmith & Nephew, Inc.JDD2015-08-29
03596010377234NASmith & Nephew, Inc.JDD2015-08-29
03596010377241NASmith & Nephew, Inc.JDD2015-08-29
03596010377258NASmith & Nephew, Inc.JDD2015-08-29
03596010377265NASmith & Nephew, Inc.JDD2015-08-29
03596010377272NASmith & Nephew, Inc.JDD2015-08-29
03596010377289NASmith & Nephew, Inc.JDD2015-08-29
03596010377296NASmith & Nephew, Inc.JDD2015-08-29
03596010377302NASmith & Nephew, Inc.JDD2015-08-29
03596010377319NASmith & Nephew, Inc.JDD2015-08-29
03596010377326NASmith & Nephew, Inc.JDD2015-08-29
03596010377333NASmith & Nephew, Inc.JDD2015-08-29
03596010377340NASmith & Nephew, Inc.JDD2015-08-29
03596010377357NASmith & Nephew, Inc.JDD2015-08-29
03596010377364NASmith & Nephew, Inc.JDD2015-08-29
03596010377371NASmith & Nephew, Inc.JDD2015-08-29
03596010377388NASmith & Nephew, Inc.JDD2015-08-29
03596010377395NASmith & Nephew, Inc.JDD2015-08-29
03596010377401NASmith & Nephew, Inc.JDD2015-08-29
03596010377418NASmith & Nephew, Inc.JDD2015-08-29
03596010377425NASmith & Nephew, Inc.JDD2015-08-29