FDA.reportPublic FDA data

Trilogy®

Primary DI
00889024360433
Brand
Trilogy®
Company
Zimmer, Inc.
Model
6110-50-26
Catalog number
00-6110-050-26
Published
2015-09-24
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
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
MLRSterilizer, chemical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
MLRSterilizer, ChemicalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K934765000
K972774000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K934765000TRILOGY ACETABULAR SYSTEMZimmer, Inc.1994-04-29LPH
K972774000GAS PLASMA STERILIZATIONZimmer, Inc.1999-05-05JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024360433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024360433008890243604338890243604330889024360433

GMDN Terms#

Term, Definition table
TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Lumen/Inner Diameter26Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
056038268
Device count
1
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
07611996098075POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098082POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098099POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098105POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098112POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098129POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098136POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098143POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098150POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098174POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098501POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098518POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098525POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098532POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111323POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111330POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111354POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111378POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111392POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111408POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111415POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111422POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111446POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111514POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111538POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111552POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996112320POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996112351POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996112368POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996114638POLARCUPSmith & Nephew, Inc.LPH2015-11-25