FDA.reportPublic FDA data

NA

Primary DI
00889024135369
Brand
NA
Company
Zimmer, Inc.
Model
00-7806-010-01
Catalog number
00-7806-010-01
Published
2016-07-25
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
FZOCHISEL, SURGICAL, MANUAL
HWMOSTEOTOME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZOChisel, Surgical, ManualGeneral, Plastic Surgery1
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024135369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024135369008890241353698890241353690889024135369

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@zimmer.com
+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
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
00889024081277XtraFix® Large External Fixation System00-5210-050-0300-5210-050-032016-09-28
00889024081284XtraFix® Large External Fixation System00-5210-050-0400-5210-050-042016-09-28
00889024081307XtraFix® Large External Fixation System00-5210-050-0600-5210-050-062016-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806373887697BENCOX Surgical InstrumentsCorentec Co., LtdFZO2026-04-10
09348811099624INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
09348811110442INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
09348811111289INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
10381780184225Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-09-12
10381780184324Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-09-12
10381780217756Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-09-12
10381780217763Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-09-12
10381780217787Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-09-12
10381780407515Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2018-05-03
10381780408536Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-05-03
10381780408543Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-05-03
10381780408550Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-05-03
10381780408673Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-05-03
10381780401476Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-05-02
10381780401483Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-05-02
10381780203803Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-04-18
10381780193098Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2018-04-03
10381780193838Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2018-04-03
10381780193845Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2018-04-03
10381780460442Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-04-03
10381780460640Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-04-03
10381780460657Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-04-03
10381780460732Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-04-03
10381780460749Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-04-03
10381780187448Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-04-02
10381780187455Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-04-02
10381780187462Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-04-02
10381780187479Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-04-02
10381780187486Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFZO2018-04-02