FDA.reportPublic FDA data

Fitmore

Primary DI
00889024470941
Brand
Fitmore
Company
Zimmer GmbH
Model
01.00555.309
Catalog number
01.00555.309
Published
2017-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWLProsthesis, hip, hemi-, femoral, metal
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024470941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024470941008890244709418890244709410889024470941

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manualA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048844693367implaFit®implantcast GmbHKWY2026-03-26
04048844693411implaFit®implantcast GmbHKWY2026-03-26
04048844693442implaFit®implantcast GmbHKWY2026-03-26
04048844693510implaFit®implantcast GmbHKWY2026-03-26
04048844693565implaFit®implantcast GmbHKWY2026-03-26
04048844693596implaFit®implantcast GmbHKWY2026-03-26
04048844732103n/aimplantcast GmbHKWY2026-03-24
04048844731984implaFit®implantcast GmbHKWY2026-03-20
04048844731991implaFit®implantcast GmbHKWY2026-03-20
04048844732028implaFit®implantcast GmbHKWY2026-03-20
10885862639622AcuMatchExactech, Inc.KWY2026-03-19
10885862661227N/AExactech, Inc.KWY2026-03-19
10885862661241N/AExactech, Inc.KWY2026-03-19
10885862661265N/AExactech, Inc.KWY2026-03-19
10885862663160AcuMatchExactech, Inc.KWY2026-03-19
00887868551611StageOne SelectBiomet Orthopedics, LLCKWL2026-03-17
00887868551628StageOne SelectBiomet Orthopedics, LLCKWL2026-03-17
00887868551635StageOne SelectBiomet Orthopedics, LLCKWY2026-03-17
00887868551659StageOne SelectBiomet Orthopedics, LLCKWL2026-03-17
00887868551666StageOne SelectBiomet Orthopedics, LLCKWL2026-03-17
00887868551673StageOne SelectBiomet Orthopedics, LLCKWY2026-03-17
00887868551680StageOne SelectBiomet Orthopedics, LLCKWL2026-03-17
04048844693350implaFit®implantcast GmbHKWY2026-03-17
04048844693374implaFit®implantcast GmbHKWY2026-03-17
04048844693381implaFit®implantcast GmbHKWY2026-03-17
04048844693398implaFit®implantcast GmbHKWY2026-03-17
04048844693404implaFit®implantcast GmbHKWY2026-03-17
04048844693428implaFit®implantcast GmbHKWY2026-03-17
04048844693435implaFit®implantcast GmbHKWY2026-03-17
04048844693459implaFit®implantcast GmbHKWY2026-03-17