Metalogix Revolution 900109

GUDID 00840124521285

3mm Pin Cap

FUSION ORTHOPEDICS, LLC

Bone nail end-cap
Primary Device ID00840124521285
NIH Device Record Key76dc540d-2584-4cc9-b4c0-fc81d9231275
Commercial Distribution StatusIn Commercial Distribution
Brand NameMetalogix Revolution
Version Model Number900109
Catalog Number900109
Company DUNS080307067
Company NameFUSION ORTHOPEDICS, LLC
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840124521285 [Primary]

FDA Product Code

JDTCap, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840124521285]

Moist Heat or Steam Sterilization


[00840124521285]

Moist Heat or Steam Sterilization


[00840124521285]

Moist Heat or Steam Sterilization


[00840124521285]

Moist Heat or Steam Sterilization


[00840124521285]

Moist Heat or Steam Sterilization


[00840124521285]

Moist Heat or Steam Sterilization


[00840124521285]

Moist Heat or Steam Sterilization


[00840124521285]

Moist Heat or Steam Sterilization


[00840124521285]

Moist Heat or Steam Sterilization


[00840124521285]

Moist Heat or Steam Sterilization


[00840124521285]

Moist Heat or Steam Sterilization


[00840124521285]

Moist Heat or Steam Sterilization


[00840124521285]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-31
Device Publish Date2025-07-23

On-Brand Devices [Metalogix Revolution]

008401245213156mm Pin Cap
008401245213085mm Pin Cap
008401245212924mm Pin Cap
008401245212853mm Pin Cap
00850069061012Standard Bolt
008500690618075x60x165mm Self-Drill Half-Pin
008500690617915x60x165mm Self-Drill Half-Pin
008401245212094x30x165mm Short Self-Drill Half-Pin
008401245211934x20x165mm Short Self-Drill Half-Pin
008401245211863x30x165mm Short Self-Drill Half-Pin
008401245211793x20x165mm Short Self-Drill Half-Pin
008401245211315x40x165mm Self-Drill Half-Pin
008401245211245x30x165mm Self-Drill Half-Pin

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