M6 Extractor 9095.11.650

GUDID 08033390093934

M6 Extractor

LIMACORPORATE SPA

Orthopaedic implant inserter/extractor, reusable
Primary Device ID08033390093934
NIH Device Record Keyb80f02eb-0d09-4cb0-878f-98c8d81288f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameM6 Extractor
Version Model NumberExtractor
Catalog Number9095.11.650
Company DUNS432066322
Company NameLIMACORPORATE SPA
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108033390093934 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390093934]

Moist Heat or Steam Sterilization


[08033390093934]

Moist Heat or Steam Sterilization


[08033390093934]

Moist Heat or Steam Sterilization


[08033390093934]

Moist Heat or Steam Sterilization


[08033390093934]

Moist Heat or Steam Sterilization


[08033390093934]

Moist Heat or Steam Sterilization


[08033390093934]

Moist Heat or Steam Sterilization


[08033390093934]

Moist Heat or Steam Sterilization


[08033390093934]

Moist Heat or Steam Sterilization


[08033390093934]

Moist Heat or Steam Sterilization


[08033390093934]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-23
Device Publish Date2016-08-05

Devices Manufactured by LIMACORPORATE SPA

08033390061230 - SMR System2025-09-15 SMR System - Reverse HP Glenosphere Dia. 40mm
08033390061254 - SMR System2025-09-15 SMR System - Reverse HP Liner Short Dia. 40mm
08033390061278 - SMR System2025-09-15 SMR System - Reverse HP Liner Medium Dia. 40mm
08033390061292 - SMR System2025-09-15 SMR System - Reverse HP Liner Long Dia. 40mm
08033390061322 - SMR System2025-09-15 SMR System - Reverse HP lateralizing Liner Medium Dia. 40mm
08033390061339 - SMR System2025-09-15 SMR System - Reverse HP lateralizing Liner Long Dia. 40mm
08033390064675 - SMR Shoulder2025-09-15 SMR Shoulder - Trial Glenosphere Positioner
08033390101806 - SMR System2025-09-15 SMR System - Reverse Trial Liner Dia.44mm Short

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.