FDA.report

G7 ACETABULAR LINER

Primary DI
00880304526983
Brand
G7 ACETABULAR LINER
Company
Biomet Orthopedics, LLC
Model
010000921
Catalog number
010000921
Published
2020-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OQHHip, semi-constrained, cemented, metal/polymer + additive, cemented

Product Code Classifications

CodeDeviceSpecialtyClass
OQHHip, Semi-Constrained, Cemented, Metal/Polymer + Additive, CementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00880304526983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304526983008803045269838803045269830880304526983

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags

DUNS number
129278169
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00887868551611StageOne Select4311904311902026-03-17
00887868551628StageOne Select4311914311912026-03-17
00887868551635StageOne Select4311924311922026-03-17
00887868551642StageOne Select4311934311932026-03-17
00887868551659StageOne Select4311944311942026-03-17
00887868551666StageOne Select4311954311952026-03-17
00887868551673StageOne Select4311964311962026-03-17
00887868551680StageOne Select4311974311972026-03-17
00887868551697StageOne Select4311984311982026-03-17
00887868551703STAGEONE SELECT4311994311992026-03-17
00889024706774Biomet®32-34169232-3416922026-03-12
00889024706781Biomet®32-14815332-1481532026-03-12
00889024706798Biomet®32-14815132-1481512026-03-12
00889024706804Biomet®32-34169732-3416972026-03-12
00889024706811Biomet®32-14814932-1481492026-03-12
00889024706484Vanguard®32-34702132-3470212026-02-27
00880304009615BMP CABLE CUTTER4980104980102020-05-23
00880304387676OPEN END CUTTER4980234980232020-05-23

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00889024686724G7® Revision Acetabular SystemZimmer, Inc.OQH2026-02-10
00887868560972Inserter/Extractor Threads Removal InstrumentBiomet Orthopedics, LLCOQH2023-07-24
00887868466298G7®Biomet Orthopedics, LLCOQH2022-10-03
00887868466335G7®Biomet Orthopedics, LLCOQH2022-06-22
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00887868469251Arcos® One-Piece Revision SystemBiomet Orthopedics, LLCOQH2022-06-22
00887868469787Echo® Bi-Metric® Hip SystemBiomet Orthopedics, LLCOQH2022-06-22
00889024588387G7® Freedom® Vivacit-E®Zimmer, Inc.OQH2022-05-17
00889024588530G7® Freedom® Vivacit-E®Zimmer, Inc.OQH2022-05-17
00889024588608G7® Freedom® Vivacit-E®Zimmer, Inc.OQH2022-05-17
00889024588615G7® Freedom® Vivacit-E®Zimmer, Inc.OQH2022-05-17
00889024588639G7® Freedom® Vivacit-E®Zimmer, Inc.OQH2022-05-17
00887868469602Echo® Bi-Metric® Microplasty® Hip StemBiomet Orthopedics, LLCOQH2022-04-23
00887868469640Echo® Bi-Metric® Microplasty® Hip StemBiomet Orthopedics, LLCOQH2022-04-23
00887868460753G7®Biomet Orthopedics, LLCOQH2021-11-21
00887868460876G7®Biomet Orthopedics, LLCOQH2021-05-20
00887868460975G7®Biomet Orthopedics, LLCOQH2021-05-20
00887868460999G7®Biomet Orthopedics, LLCOQH2021-05-20
00887868461149G7®Biomet Orthopedics, LLCOQH2021-05-20
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00887868461392G7®Biomet Orthopedics, LLCOQH2021-05-20
00887868461491G7®Biomet Orthopedics, LLCOQH2021-05-20
00887868461590G7®Biomet Orthopedics, LLCOQH2021-05-20
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