FDA.reportPublic FDA data

Endohead

Primary DI
07630030806247
Brand
Endohead
Company
Medacta International SA
Model
01.25.241M
Device description
Medacta Endo Head Ø 41, M
Published
2014-11-18
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
LZYProsthesis, Hip, Hemi-, Femoral, Metal Ball

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZYProsthesis, Hip, Hemi-, Femoral, Metal BallOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111145000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111145000ENDO HEADMedacta International2011-08-16LZY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630030806247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630030806247076300308062477630030806247

GMDN Terms#

Term, Definition table
TermDefinition
Femoral head bipolar componentA sterile implantable hemisphere-shaped device used as part of a partial hip replacement (femoral) and designed to interface with the acetabulum on its outer surface where it freely rotates, and interface with a femoral head prosthesis on its inner surface where it allows free rotation of the head. It is a one-piece device typically composed of an outer metal shell (e.g., titanium alloy) and an inner polyethylene (PE) liner; it is typically used for older femoral fracture patients.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
488227125
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630971243637AMIStem-P Short Neck01.18.4592020-01-29
07630971243644AMIStem-P Short Neck01.18.4602020-01-29
07630971243651AMIStem-P Short Neck01.18.4612020-01-29
07630971243668AMIStem-P Short Neck01.18.4622020-01-29
07630971243675AMIStem-P Short Neck01.18.4632020-01-29
07630971243682AMIStem-P Short Neck01.18.4642020-01-29
07630971243699AMIStem-P Short Neck01.18.4652020-01-29
07630971243705AMIStem-P Short Neck01.18.4662020-01-29
07630971243712AMIStem-P Short Neck01.18.4672020-01-29
07630971243729AMIStem-P Short Neck01.18.4682020-01-29
07630971243736AMIStem-P Short Neck01.18.4692020-01-29
07630971243743AMIStem-P Short Neck01.18.4702020-01-29
07630971243750AMIStem-P Short Neck01.18.4712020-01-29
07630971243767AMIStem-P Short Neck01.18.4722020-01-29
07630971243774AMIStem-P Short Neck01.18.4732020-01-29
07630971243781AMIStem-P Short Neck01.18.4742020-01-29
07630971243798AMIStem-P Short Neck01.18.4752020-01-29
07630971243804AMIStem-P Short Neck01.18.4762020-01-29
07630971243811AMIStem-P Short Neck01.18.4772020-01-29
07630971243828AMIStem-P Short Neck01.18.4782020-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630030804342AMIStem-H Proximal CoatingMedacta International SALZY2021-10-22
07630030804359AMIStem-H Proximal CoatingMedacta International SALZY2021-10-22
07630030804458AMIStem-H Proximal CoatingMedacta International SALZY2021-10-22
07630040719988AMIStem-PMedacta International SALZY2021-10-22
07630040719995AMIStem-PMedacta International SALZY2021-10-22
07630040720007AMIStem-PMedacta International SALZY2021-10-22
07630040720014AMIStem-PMedacta International SALZY2021-10-22
07630040720021AMIStem-PMedacta International SALZY2021-10-22
07630040720038AMIStem-PMedacta International SALZY2021-10-22
07630040720045AMIStem-PMedacta International SALZY2021-10-22
07630040720052AMIStem-PMedacta International SALZY2021-10-22
07630040720069AMIStem-PMedacta International SALZY2021-10-22
07630040720076AMIStem-PMedacta International SALZY2021-10-22
07630040720083AMIStem-PMedacta International SALZY2021-10-22
07630040720090AMIStem-PMedacta International SALZY2021-10-22
07630040720106AMIStem-PMedacta International SALZY2021-10-22
07630040720113AMIStem-PMedacta International SALZY2021-10-22
07630040720120AMIStem-PMedacta International SALZY2021-10-22
07630040720137AMIStem-PMedacta International SALZY2021-10-22
07630040720144AMIStem-PMedacta International SALZY2021-10-22
07630040720151AMIStem-PMedacta International SALZY2021-10-22
07630040720168AMIStem-PMedacta International SALZY2021-10-22
07630040720175AMIStem-PMedacta International SALZY2021-10-22
07630040720182AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720199AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720205AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720212AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720229AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720236AMIStem-P CollaredMedacta International SALZY2021-10-22
07630040720243AMIStem-P CollaredMedacta International SALZY2021-10-22