FDA.reportPublic FDA data

NA

Primary DI
00889024376748
Brand
NA
Company
Zimmer, Inc.
Model
8011-20-01
Published
2016-08-31
Public version status
Update
Distribution status
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
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
JDSNAIL, FIXATION, BONE
LZNCEMENT OBTURATOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
JDSNail, Fixation, BoneOrthopedic2
LZNCement ObturatorGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001733000
K800142000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001733000ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIESZimmer, Inc.2000-06-20JDI
K800142000FUSON BONE PLUG, RADIOPAQUEZimmer, Inc.1980-02-19JDS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024380196PackageGS132In Commercial Distribution
00889024376748PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024380196008890243801968890243801960889024380196
00889024376748008890243767488890243767480889024376748

GMDN Terms#

Term, Definition table
TermDefinition
Polymer orthopaedic cement restrictor, non-bioabsorbableA non-bioabsorbable, implantable device designed to be inserted into the medullary canal of a bone (e.g., femur, tibia, or humerus) during orthopaedic surgery to prevent cement progression in the diaphysis and therefore facilitate cement pressurization during the introduction of an implant. It is typically made of polyetheretherketone (PEEK) or ultrahigh molecular weight polyethylene (UHMWPE) and is available in a variety of designs (e.g., straight or tapered, hollow with a fenestrated surface), and it may have a toothed surface to prevent its migration from the desired location. It may incorporate a metal orientation marker for radiographs and it is not intended for spinal application.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

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

Regulatory Flags#

DUNS number
056038268
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
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
07611996074901SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074918SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074925SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074956SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074963SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074970SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996074987SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996075007SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996075021SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996075038SL-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996095609SLR-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996095616SLR-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996095623SLR-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996095654SLR-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996095661SLR-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996095685SLR-PLUSSmith & Nephew, Inc.JDI2016-08-19
07611996013788SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996013795SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996013849SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996014990BOFOR/EP-FIT PLUS/PROMOS/MPFSmith & Nephew, Inc.JDI2015-11-25
07611996045208MODULAR-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996065343SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996076394SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996081008SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996081022SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996081046SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996081077SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996081084SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996081091SL-PLUSSmith & Nephew, Inc.JDI2015-11-25
07611996081107SL-PLUSSmith & Nephew, Inc.JDI2015-11-25