FDA.reportPublic FDA data

NA

Primary DI
00889024066724
Brand
NA
Company
Zimmer, Inc.
Model
3607
Catalog number
00-3607-000-00
Published
2017-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWOSKID, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWOSkid, BoneOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024066724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024066724008890240667248890240667240889024066724

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
056038268
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00889024701465Identity® Shoulder System11007751110077512026-06-10
00889024701472Identity® Shoulder System11007752110077522026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613124106MSI Precision Specialty InstrumentsMed Saver, Inc.HWO2025-08-01
G586N98822010Novo SurgicalNOVO SURGICAL, INC.HWO2023-12-18
07708604560205SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2023-01-18
07708604560359SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2023-01-18
00842331138850Novo Surgical Inc. NOVO SURGICAL, INC.HWO2022-11-11
07708604560014SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2022-05-12
07708604560106SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2022-05-12
07708626670159SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2022-05-12
07708626670777SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2022-05-12
07708626670906SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2022-05-12
07708604560038SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2022-05-09
00190776183660MillenniumAvalign Technologies, Inc.HWO2021-11-01
10381780183372Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWO2018-01-24
10381780433972Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWO2018-01-24
M2742254251Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWO2018-01-24
M2742254201Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWO2018-01-24
10381780427179Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWO2018-01-10
H834276800Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWO2018-01-10
00889024066717NAZimmer, Inc.HWO2016-07-27