FDA.report

System 12

Primary DI
07613153076292
Brand
System 12
Company
Howmedica Osteonics Corp.
Model
6302-6-266
Catalog number
6302-6-266
Device description
Lateralizing Insert
Published
2015-09-24
Public version status
Update
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

Product Codes

CodeName
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Product Code Classifications

CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613153076292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613153076292076131530762927613153076292

GMDN Terms

TermDefinition
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 may include a stabilizing component (e.g., a ring) to limit the range of motion of the hip to help prevent dislocation.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter26Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
058311945
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07613327660180Instrument5533-T-409-R5533-T-409-R2026-02-27
07613327648386Instrument5533-T-812-R5533-T-812-R2026-02-26
07613327648393Instrument5533-T-811-L5533-T-811-L2026-02-26
07613327648409Instrument5533-T-812-L5533-T-812-L2026-02-26
07613327648416Instrument5533-T-810-R5533-T-810-R2026-02-26
07613327648423Instrument5533-T-816-L5533-T-816-L2026-02-26
07613327648430Instrument5533-T-809-L5533-T-809-L2026-02-26
07613327648447Instrument5533-T-814-R5533-T-814-R2026-02-26
07613327648454Instrument5533-T-809-R5533-T-809-R2026-02-26
07613327648461Instrument5533-T-810-L5533-T-810-L2026-02-26
07613327648478Instrument5533-T-811-R5533-T-811-R2026-02-26
07613327648485Instrument5533-T-816-R5533-T-816-R2026-02-26
07613327648492Instrument5533-T-814-L5533-T-814-L2026-02-26
07613327651485Instrument5533-T-010-R5533-T-010-R2026-02-26
07613327651492Instrument5533-T-012-R5533-T-012-R2026-02-26
07613327651508Instrument5533-T-016-R5533-T-016-R2026-02-26
07613327651515Instrument5533-T-011-L5533-T-011-L2026-02-26
07613327651522Instrument5533-T-014-L5533-T-014-L2026-02-26
07613327651539Instrument5533-T-009-L5533-T-009-L2026-02-26
07613327651546Instrument5533-T-016-L5533-T-016-L2026-02-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04048844732103n/aimplantcast GmbHKWY2026-03-24
04048844731984implaFit®implantcast GmbHKWY2026-03-20
04048844731991implaFit®implantcast GmbHKWY2026-03-20
04048844732028implaFit®implantcast GmbHKWY2026-03-20
10885862639622AcuMatchExactech, Inc.KWY2026-03-19
10885862661227N/AExactech, Inc.KWY2026-03-19
10885862661241N/AExactech, Inc.KWY2026-03-19
10885862661265N/AExactech, Inc.KWY2026-03-19
10885862663160AcuMatchExactech, Inc.KWY2026-03-19
00887868551635StageOne SelectBiomet Orthopedics, LLCKWY2026-03-17
00887868551673StageOne SelectBiomet Orthopedics, LLCKWY2026-03-17
04048844693374implaFit®implantcast GmbHKWY2026-03-17
04048844693459implaFit®implantcast GmbHKWY2026-03-17
04048844693466implaFit®implantcast GmbHKWY2026-03-17
04048844693497implaFit®implantcast GmbHKWY2026-03-17
04048844693534implaFit®implantcast GmbHKWY2026-03-17
04048844693541implaFit®implantcast GmbHKWY2026-03-17
00889024706088Z1 STARTER BROACH, HYBRIDZimmer, Inc.KWY2026-02-23
00889024706095Z1 BROACH SZ 0, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706101Z1 BROACH SZ 1, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706118Z1 BROACH SZ 2, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706125Z1 BROACH SZ 3, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706132Z1 BROACH SZ 4, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706149Z1 BROACH SZ 5, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706156Z1 BROACH SZ 6, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706163Z1 BROACH SZ 7, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706170Z1 BROACH SZ 8, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706187Z1 BROACH SZ 9, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706194Z1 BROACH SZ 10, HYBRID Zimmer, Inc.KWY2026-02-23
00889024706200Z1 BROACH SZ 11, HYBRID Zimmer, Inc.KWY2026-02-23