FDA.reportPublic FDA data

System 12

Primary DI
04546540269737
Brand
System 12
Company
Howmedica Osteonics Corp.
Model
6302-5-072
Catalog number
6302-5-072
Device description
10degrees Polyethylene 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

Product Codes#

Code, Name table
CodeName
KWLProsthesis, hip, hemi-, femoral, metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540269737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540269737045465402697374546540269737

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
Device Size Text, specify0
Lumen/Inner Diameter28Millimeter

Sterilization Methods#

Method table
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887868551611StageOne SelectBiomet Orthopedics, LLCKWL2026-03-17
00887868551628StageOne SelectBiomet Orthopedics, LLCKWL2026-03-17
00887868551659StageOne SelectBiomet Orthopedics, LLCKWL2026-03-17
00887868551666StageOne SelectBiomet Orthopedics, LLCKWL2026-03-17
00887868551680StageOne SelectBiomet Orthopedics, LLCKWL2026-03-17
08031497003955Interspace GV Hip Spacer 46TECRES SPAKWL2026-02-11
08031497003962Interspace GV Hip Spacer 54TECRES SPAKWL2026-02-11
08031497003979Interspace GV Hip Spacer 60TECRES SPAKWL2026-02-11
08031497003986Interspace GV Hip Spacer 46 XLTECRES SPAKWL2026-02-11
08031497003993Interspace GV Hip Spacer 54 XLTECRES SPAKWL2026-02-11
08031497004006Interspace GV Hip Spacer 60 XLTECRES SPAKWL2026-02-11
00822409123445TrivictaOrtho Development CorporationKWL2024-04-01
00822409123452TrivictaOrtho Development CorporationKWL2024-04-01
00822409123483TrivictaOrtho Development CorporationKWL2024-04-01
00822409123490TrivictaOrtho Development CorporationKWL2024-04-01
00822409123711TrivictaOrtho Development CorporationKWL2024-04-01
00822409123766TrivictaOrtho Development CorporationKWL2024-04-01
00822409123827TrivictaOrtho Development CorporationKWL2024-04-01
00822409123834TrivictaOrtho Development CorporationKWL2024-04-01
00822409123865TrivictaOrtho Development CorporationKWL2024-04-01
00814193025975SYNOVO HIP COMPONENTSSynovo ProductionKWL2024-03-14
00814193025982SYNOVO HIP COMPONENTSSynovo ProductionKWL2024-03-14
00814193025999SYNOVO HIP COMPONENTSSynovo ProductionKWL2024-03-14
00814193026002SYNOVO HIP COMPONENTSSynovo ProductionKWL2024-03-14
00814193026019SYNOVO HIP COMPONENTSSynovo ProductionKWL2024-03-14
00814193026026SYNOVO HIP COMPONENTSSynovo ProductionKWL2024-03-14
00814193026033SYNOVO HIP COMPONENTSSynovo ProductionKWL2024-03-14
00814193026040SYNOVO HIP COMPONENTSSynovo ProductionKWL2024-03-14
00814193026057SYNOVO HIP COMPONENTSSynovo ProductionKWL2024-03-14
00814193026064SYNOVO HIP COMPONENTSSynovo ProductionKWL2024-03-14