Mpact 3D Metal Acetabular System

GUDID 07630040723336

Compression Polyaxial Locking Screw Ø6.5 – L55 mm

Medacta International SA

Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell Acetabular shell
Primary Device ID07630040723336
NIH Device Record Key184cab02-cc19-441c-aaa8-28c0311d7b5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMpact 3D Metal Acetabular System
Version Model Number01.38.255
Company DUNS488227125
Company NameMedacta International SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107630040723336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-31
Device Publish Date2021-12-23

On-Brand Devices [Mpact 3D Metal Acetabular System]

07630971212626Acetabular shell Ø60 Multi-hole Thin
07630971212619Acetabular shell Ø58 Multi-hole Thin
07630971212602Acetabular shell Ø56 Multi-hole Thin
07630971212596Acetabular shell Ø54 Multi-hole Thin
07630971212589Acetabular shell Ø52 Multi-hole Thin
07630971212572Acetabular shell Ø50 Multi-hole Thin
07630971212565Acetabular shell Ø48 Multi-hole Thin
07630040723367Compression Polyaxial Locking Screw Ø6.5 – L70 mm
07630040723350Compression Polyaxial Locking Screw Ø6.5 – L65 mm
07630040723343Compression Polyaxial Locking Screw Ø6.5 – L60 mm
07630040723336Compression Polyaxial Locking Screw Ø6.5 – L55 mm
07630040723329Compression Polyaxial Locking Screw Ø6.5 – L50 mm
07630040723312Compression Polyaxial Locking Screw Ø6.5 – L45 mm
07630040723305Compression Polyaxial Locking Screw Ø6.5 – L40 mm
07630040723299Compression Polyaxial Locking Screw Ø6.5 – L35 mm
07630040723282Compression Polyaxial Locking Screw Ø6.5 – L30 mm
07630040723275Compression Polyaxial Locking Screw Ø6.5 – L25 mm
07630040723268Compression Polyaxial Locking Screw Ø6.5 – L20 mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.