FDA.report

VerSys®

Primary DI
00889024366756
Brand
VerSys®
Company
Zimmer, Inc.
Model
65-7862-10
Published
2017-10-02
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
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Product Code Classifications

CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889024366756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024366756008890243667568890243667560889024366756

GMDN Terms

TermDefinition
Press-fit 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 contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device may be made of metal and/or ceramic materials; supplemental fixation devices for implantation (e.g., screws and bolts) may be included.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.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

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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 DIBrandCompanyProduct codePublished
04048844732004implaFit®implantcast GmbHMEH2026-03-20
04048844732066implaFit®implantcast GmbHMEH2026-03-20
04048844781101implaFit®implantcast GmbHMEH2026-03-20
10885862660589N/AExactech, Inc.MEH2026-03-19
10885862660688N/AExactech, Inc.MEH2026-03-19
10885862660916NovationExactech, Inc.MEH2026-03-19
10885862660985N/AExactech, Inc.MEH2026-03-19
10885862660992N/AExactech, Inc.MEH2026-03-19
10885862661036N/AExactech, Inc.MEH2026-03-19
10885862661074N/AExactech, Inc.MEH2026-03-19
10885862661128N/AExactech, Inc.MEH2026-03-19
10885862661135N/AExactech, Inc.MEH2026-03-19
10885862661142N/AExactech, Inc.MEH2026-03-19
10885862661289N/AExactech, Inc.MEH2026-03-19
10885862661296N/AExactech, Inc.MEH2026-03-19
10885862661302NovationExactech, Inc.MEH2026-03-19
10885862661319NovationExactech, Inc.MEH2026-03-19
10885862661326NovationExactech, Inc.MEH2026-03-19
10885862661333NovationExactech, Inc.MEH2026-03-19
10885862661340NovationExactech, Inc.MEH2026-03-19
10885862661357NovationExactech, Inc.MEH2026-03-19
04048844693350implaFit®implantcast GmbHMEH2026-03-17
04048844693381implaFit®implantcast GmbHMEH2026-03-17
04048844693398implaFit®implantcast GmbHMEH2026-03-17
04048844693503implaFit®implantcast GmbHMEH2026-03-17
04048844693527implaFit®implantcast GmbHMEH2026-03-17
07630542790799Mfinity Femoral SystemMedacta International SAMEH2026-02-27
07630542790805Mfinity Femoral SystemMedacta International SAMEH2026-02-27
07630542790812Mfinity Femoral SystemMedacta International SAMEH2026-02-27
07630542790829Mfinity Femoral SystemMedacta International SAMEH2026-02-27