FDA.reportPublic FDA data

Ceramic femoral head

Primary DI
03662200028436
Brand
Ceramic femoral head
Company
SOC ETUDES RECHERCHES FABRICATION
Model
D28-CL
Catalog number
RM30660003
Published
2024-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223745000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223745000Novae® Dual Mobility System, Hype® Hip SystemSerf2023-12-22LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662200004126PreviousGS10
03662200028436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662200004126036622000041263662200004126
03662200028436036622000284363662200028436

GMDN Terms#

Term, Definition table
TermDefinition
Ceramic femoral head prosthesisAn implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
282651413
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03662200033126Trays associated with hip instrumentsRA999900622024-09-17
03662200005796CI ECI 41/22,2 E2015-09-01
03662200005802CI ECI 43/22,2 E2015-09-01
03662200005819CI ECI 45/22,2 E2015-09-01
03662200005826CI ECI 47/22,2 E2015-09-01
03662200005833CI ECI 49/22,2 E2015-09-01
03662200005840CI ECI 51/22,2 E2015-09-01
03662200005857CI ECI 53/22,2 E2015-09-01
03662200005864CI ECI 55/22,2 E2015-09-01
03662200005871CI ECI 57/22,2 E2015-09-01
03662200005888CI ECI 59/22,2 E2015-09-01
03662200005895CI ECI 61/22,2 E2015-09-01
03662200005901CI ECI 63/22,2 E2015-09-01
03662200005918CI ECI 65/22,2 E2015-09-01
03662200005925CI ECI 67/22,2 E2015-09-01
03662200005932CI ECI 69/22,2 E2015-09-01
03662200005963CI ECI 47/28 E2015-09-01
03662200005970CI ECI 49/28 E2015-09-01
03662200005987CI ECI 51/28 E2015-09-01
03662200005994CI ECI 53/28 E2015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630542796555Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796562Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796579Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796586Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796593Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796609Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796616Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796623Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796630Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796647Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796654Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796661Mfinity Femoral SystemMedacta International SAMEH2026-08-25
05056139247293Icona Hip StemCORIN LTDMEH2025-04-07
05056139247293Icona Hip StemCORIN LTDLZO2025-04-07
10885862022448NAExactech, Inc.MEH2022-09-19
10885862022448NAExactech, Inc.LZO2022-09-19
10885862022455NAExactech, Inc.LZO2022-09-19
10885862022455NAExactech, Inc.MEH2022-09-19
10885862029867NAExactech, Inc.LZO2022-09-19
10885862034038NovationExactech, Inc.LZO2022-09-19
10885862034038NovationExactech, Inc.MEH2022-09-19
10885862034045NovationExactech, Inc.MEH2022-09-19
10885862034045NovationExactech, Inc.LZO2022-09-19
10885862034052NovationExactech, Inc.MEH2022-09-19
10885862034052NovationExactech, Inc.LZO2022-09-19
10885862034069NovationExactech, Inc.LZO2022-09-19
10885862034069NovationExactech, Inc.MEH2022-09-19
10885862034076NovationExactech, Inc.LZO2022-09-19
10885862034076NovationExactech, Inc.MEH2022-09-19
10885862034083NovationExactech, Inc.LZO2022-09-19