FDA.reportPublic FDA data

NA

Primary DI
00889024115125
Brand
NA
Company
Zimmer, Inc.
Model
4555-07
Published
2016-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDDPROSTHESIS, UPPER FEMORAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDDProsthesis, Upper FemoralOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024115125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024115125008890241151258890241151250889024115125

GMDN Terms#

Term, Definition table
TermDefinition
Femoral head/stem prosthesis adaptorA sterile implantable tubular device designed to connect a femoral head prosthesis to the trunnion of a femoral stem prosthesis. It is typically intended to be used as part of a total hip arthroplasty (THA) revision to correct offset, neck length, lateralization, and anteversion/retroversion where there is a good fitting stem; it may also be used as part of a primary procedure. It is made of metal [e.g., titanium (Ti) alloy] and is available in various sizes and shapes; it is intended to be used with a dedicated femoral head prosthesis.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
056038268
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
03596010377135NASmith & Nephew, Inc.JDD2015-08-29
03596010377142NASmith & Nephew, Inc.JDD2015-08-29
03596010377159NASmith & Nephew, Inc.JDD2015-08-29
03596010377166NASmith & Nephew, Inc.JDD2015-08-29
03596010377173NASmith & Nephew, Inc.JDD2015-08-29
03596010377180NASmith & Nephew, Inc.JDD2015-08-29
03596010377197NASmith & Nephew, Inc.JDD2015-08-29
03596010377203NASmith & Nephew, Inc.JDD2015-08-29
03596010377210NASmith & Nephew, Inc.JDD2015-08-29
03596010377227NASmith & Nephew, Inc.JDD2015-08-29
03596010377234NASmith & Nephew, Inc.JDD2015-08-29
03596010377241NASmith & Nephew, Inc.JDD2015-08-29
03596010377258NASmith & Nephew, Inc.JDD2015-08-29
03596010377265NASmith & Nephew, Inc.JDD2015-08-29
03596010377272NASmith & Nephew, Inc.JDD2015-08-29
03596010377289NASmith & Nephew, Inc.JDD2015-08-29
03596010377296NASmith & Nephew, Inc.JDD2015-08-29
03596010377302NASmith & Nephew, Inc.JDD2015-08-29
03596010377319NASmith & Nephew, Inc.JDD2015-08-29
03596010377326NASmith & Nephew, Inc.JDD2015-08-29
03596010377333NASmith & Nephew, Inc.JDD2015-08-29
03596010377340NASmith & Nephew, Inc.JDD2015-08-29
03596010377357NASmith & Nephew, Inc.JDD2015-08-29
03596010377364NASmith & Nephew, Inc.JDD2015-08-29
03596010377371NASmith & Nephew, Inc.JDD2015-08-29
03596010377388NASmith & Nephew, Inc.JDD2015-08-29
03596010377395NASmith & Nephew, Inc.JDD2015-08-29
03596010377401NASmith & Nephew, Inc.JDD2015-08-29
03596010377418NASmith & Nephew, Inc.JDD2015-08-29
03596010377425NASmith & Nephew, Inc.JDD2015-08-29