FDA.reportPublic FDA data

Endohead

Primary DI
07630030806292
Brand
Endohead
Company
Medacta International SA
Model
01.25.243L
Device description
Medacta Endo Head Ø 43, L
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
07630030806292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630030806292076300308062927630030806292

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
07630699705950Shoulder System04.01.10.12142026-10-01
07630699705967Shoulder System04.01.10.12152026-10-01
07630699705974Shoulder System04.01.10.12162026-10-01
07630699705998Shoulder System04.01.10.12182026-10-01
07630699706001Shoulder System04.01.10.12192026-10-01
07630699706018Shoulder System04.01.10.12202026-10-01
07630699706032Shoulder System04.01.10.12222026-10-01
07630699706049Shoulder System04.01.10.12232026-10-01
07630699706056Shoulder System04.01.10.12242026-10-01
07630345775320Shoulder System04.01.10.06972026-09-28
07630345775375Shoulder System04.01.10.07022026-09-28
07630542727528Shoulder System04.01.10.08812026-09-28
07630542727535Shoulder System04.01.10.08822026-09-28
07630542727542Shoulder System04.01.10.08832026-09-28
07630542727559Shoulder System04.01.10.08842026-09-28
07630542794964Surgical Manual Instrument04.01.10.10132026-09-28
07630542794971Surgical Manual Instrument04.01.10.10142026-09-28
07630542794988Surgical Manual Instrument04.01.10.10152026-09-28
07630542794995Surgical Manual Instrument04.01.10.10162026-09-28
07630542795008Shoulder System04.01.10.10172026-09-28

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