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
00889024707382Persona Tensor Sizer Arm – LongSSI008513SSI0085132026-05-29
00889024707399Persona Tensor Sizer Arm – StdSSI008567SSI0085672026-05-29
00889024707405Persona Tensor Sizer BodySSI008566SSI0085662026-05-29
00889024081024XtraFix® Large External Fixation System00-5207-024-3000-5207-024-302016-08-09
00889024081055XtraFix® Large External Fixation System00-5207-032-3000-5207-032-302016-07-27
00889024081062XtraFix® Large External Fixation System00-5207-040-1000-5207-040-102016-07-28
00889024081079XtraFix® Large External Fixation System00-5207-040-7000-5207-040-702016-07-28
00889024081086XtraFix® Large External Fixation System00-5207-045-1000-5207-045-102016-07-28
00889024081093XtraFix® Large External Fixation System00-5210-009-0100-5210-009-012016-09-28
00889024081109XtraFix® Large External Fixation System00-5210-009-0200-5210-009-022016-09-28
00889024081147XtraFix® Large External Fixation System00-5210-019-0100-5210-019-012016-09-28
00889024081154XtraFix® Large External Fixation System00-5210-029-0100-5210-029-012016-09-28
00889024081178XtraFix® Large External Fixation System00-5210-040-0000-5210-040-002016-09-28
00889024081185XtraFix® Large External Fixation System00-5210-040-0100-5210-040-012016-09-28
00889024081192XtraFix® Large External Fixation System00-5210-040-0200-5210-040-022016-09-28
00889024081208XtraFix® Large External Fixation System00-5210-040-0300-5210-040-032016-09-28
00889024081215XtraFix® Large External Fixation System00-5210-040-0400-5210-040-042016-09-28
00889024081239XtraFix® Large External Fixation System00-5210-040-0600-5210-040-062016-09-28
00889024081253XtraFix® Large External Fixation System00-5210-050-0100-5210-050-012016-09-28
00889024081260XtraFix® Large External Fixation System00-5210-050-0200-5210-050-022016-09-28

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