SURGEON SPECIFIC ANATOMIC RESECTION JIG 9CCA.13.005

GUDID 08033390111539

Surgeon specific anatomic resection jig - SMR Shoulder

LIMACORPORATE SPA

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID08033390111539
NIH Device Record Keya82cdbaf-ca6d-4760-82ab-2bcdfbfb8829
Commercial Distribution StatusIn Commercial Distribution
Brand NameSURGEON SPECIFIC ANATOMIC RESECTION JIG
Version Model NumberSURGEON SPECIFIC ANATOMIC RESECTION JIG
Catalog Number9CCA.13.005
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
GS108033390111539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390111539]

Moist Heat or Steam Sterilization


[08033390111539]

Moist Heat or Steam Sterilization


[08033390111539]

Moist Heat or Steam Sterilization


[08033390111539]

Moist Heat or Steam Sterilization


[08033390111539]

Moist Heat or Steam Sterilization


[08033390111539]

Moist Heat or Steam Sterilization


[08033390111539]

Moist Heat or Steam Sterilization


[08033390111539]

Moist Heat or Steam Sterilization


[08033390111539]

Moist Heat or Steam Sterilization


[08033390111539]

Moist Heat or Steam Sterilization


[08033390111539]

Moist Heat or Steam Sterilization


[08033390111539]

Moist Heat or Steam Sterilization


[08033390111539]

Moist Heat or Steam Sterilization


[08033390111539]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-05-03
Device Publish Date2016-08-05

Devices Manufactured by LIMACORPORATE SPA

08033390278263 - ProMade Shoulder2025-02-24 ProMade Shoulder - Trial Eccentric Glenosphere Dia. 36 mm
08033390282765 - ProMade Shoulder2025-02-24 ProMade Shoulder - Trial Eccentric Glenosphere Dia. 40 mm
08033390282772 - ProMade Shoulder2025-02-24 ProMade Shoulder - Trial Glenosphere Dia. 36 mm
08033390282789 - ProMade Shoulder2025-02-24 ProMade Shoulder - Trial Glenosphere Dia. 40 mm
08033390290654 - TEMA Elbow2024-12-30 TEMA Elbow - T15 Screwdriver Shaft for Axle Removal
08033390290661 - TEMA Elbow2024-12-30 TEMA Elbow - Sleeve for Axle Removal Large
08033390290678 - TEMA Elbow2024-12-30 TEMA Elbow - Sleeve for Axle Removal Small
08033390282642 - ProMade Shoulder2024-08-15 ProMade Shoulder - Long Helix Drill Dia. 3,5 mm

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