FDA.report

Fitmore® Hip Stem

Primary DI
00889024281141
Brand
Fitmore® Hip Stem
Company
Zimmer GmbH
Model
01.00551.114
Device description
Fitmore Hip Stem A, Size 14
Published
2016-11-07
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
JDLProsthesis, hip, semi-constrained (metal cemented acetabular component)

Product Code Classifications

CodeDeviceSpecialtyClass
JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)Orthopedic3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889024281141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024281141008890242811418890242811410889024281141

GMDN Terms

TermDefinition
Coated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) 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)348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags

DUNS number
488133448
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 DIBrandModelCatalogPublished
00889024292512NCB®02.02261.0132024-05-03
00889024292550NCB®02.02261.1132024-05-03
00889024296558NCB®02.03156.0902024-05-03
00889024296565NCB®02.03156.0952024-05-03
00889024296572NCB®02.03156.1002024-05-03
00889024593152Wagner Cone Prosthesis®01.00561.31301.00561.3132022-12-13
00889024593176Wagner Cone Prosthesis®01.00561.21501.00561.2152022-12-13
00889024593183Wagner Cone Prosthesis®01.00561.21601.00561.2162022-12-13
00889024593190Wagner Cone Prosthesis®01.00561.21701.00561.2172022-12-13
00889024593206Wagner Cone Prosthesis®01.00561.31401.00561.3142022-12-13
00889024593213Wagner Cone Prosthesis®01.00561.21801.00561.2182022-12-13
00889024593237Wagner Cone Prosthesis®01.00561.21901.00561.2192022-12-13
00889024593251Wagner Cone Prosthesis®01.00561.31701.00561.3172022-12-13
00889024593268Wagner Cone Prosthesis®01.00561.31801.00561.3182022-12-13
00889024593534Wagner SL Revision®01.00102.62401.00102.6242022-12-13
00889024593541Wagner SL Revision®01.00102.62501.00102.6252022-12-13
00889024593145Wagner Cone Prosthesis®01.00561.21301.00561.2132022-12-13
00889024593169Wagner Cone Prosthesis®01.00561.21401.00561.2142022-12-13
00889024593220Wagner Cone Prosthesis®01.00561.31501.00561.3152022-12-13
00889024593244Wagner Cone Prosthesis®01.00561.31601.00561.3162022-12-13

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