FDA.reportPublic FDA data

PCA

Primary DI
07613327138658
Brand
PCA
Company
Howmedica Osteonics Corp.
Model
6299-N-322
Catalog number
6299-N-322
Device description
Constrained Acetabular 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
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063445000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063445000PCA CONSTRAINED ACETABULAR LINERSHowmedica Osteonics Corp.2007-03-08KWZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327138658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327138658076133271386587613327138658

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter22Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327259797INSTRUMENT1100-2800R1100-2800R2016-09-24
07613327138078SOLAR5351-41085351-41082015-09-24
04546540167415EXETER0942-2-1100942-2-1102015-09-24
04546540167422EXETER0942-2-1120942-2-1122015-09-24
04546540167439EXETER0942-2-1140942-2-1142015-09-24
04546540167446EXETER0942-2-1160942-2-1162015-09-24
04546540167453EXETER0942-2-1180942-2-1182015-09-24
04546540167460EXETER0942-2-1200942-2-1202015-09-24
07613327245158INSTRUMENT6543-4-8186543-4-8182017-11-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613153071273RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071297RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071310RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071327RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071334RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071341RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071365RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071372RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071389RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071396RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071402RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071419RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071426RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071433RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071440RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071587RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071594RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071600RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071617RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071648RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153071655RestorationHowmedica Osteonics Corp.KWZ2015-09-24
07613153072867TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072874TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072881TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072898TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072904TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072911TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072928TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072935TridentHowmedica Osteonics Corp.KWZ2015-09-24
07613153072942TridentHowmedica Osteonics Corp.KWZ2015-09-24