EXPERT - Flexible Joint Fixation System 312-14-07-4

GUDID 07899258663739

EXPERT ACL TIBIA - Flexible ACL Tibial Knotless Fixator with adjustable wire – concave button 14mm /7mm

GM DOS REIS INDUSTRIA E COMERCIO LTDA

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID07899258663739
NIH Device Record Key095c8f67-bbc6-497c-b28c-be96cf223ad0
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXPERT - Flexible Joint Fixation System
Version Model NumberEXPERT ACL TIBIA - 14mm/7mm
Catalog Number312-14-07-4
Company DUNS900865213
Company NameGM DOS REIS INDUSTRIA E COMERCIO LTDA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS107899258663739 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTNWasher, Bolt Nut

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-13
Device Publish Date2024-11-05

On-Brand Devices [EXPERT - Flexible Joint Fixation System]

07899258663869EXPERT FAST DUAL - Dual Flexible Knotless Fixator for Syndesmosis with Inserter
07899258663852Support Plate for Expert ACL
07899258663845EXPERT ACL TIBIAL TAPE - Flexible ACL Tibial Knotless Fixator with adjustable tape – concave b
07899258663838EXPERT ACL TIBIAL TAPE - Flexible ACL Tibial Knotless Fixator with adjustable tape – concave b
07899258663821EXPERT ACL TIBIAL TAPE - Flexible ACL Tibial Knotless Fixator with adjustable tape – concave b
07899258663814EXPERT ACL II with augmentation - Flexible ACL II Knotless Fixator with adjustable tape and liga
07899258663807EXPERT ACL II – Flexible ACL II Knotless Fixator with adjustable tape
07899258663791EXPERT ACL with augmentation - Flexible ACL Knotless Fixator with adjustable wire and tape for l
07899258663784EXPERT ACL – Flexible ACL Knotless Fixator with adjustable wire
07899258663777EXPERT ACL TIBIA - Concave Button 20mm /9mm
07899258663760EXPERT ACL TIBIA - Concave Button 14mm /7mm
07899258663753EXPERT ACL TIBIA - Concave Button 11mm /4mm
07899258663746EXPERT ACL TIBIA - Flexible ACL Tibial Knotless Fixator with adjustable wire – concave button
07899258663739EXPERT ACL TIBIA - Flexible ACL Tibial Knotless Fixator with adjustable wire – concave button
07899258663722EXPERT ACL TIBIA - Flexible ACL Tibial Knotless Fixator with adjustable wire – concave button
07899258662268EXPERT FAST - CORACOID PLATE - Flexible Knotless Fixator Coracoid Plate with Inserter
07899258661933EXPERT FAST- AC - Flexible Knotless Fixator Acromioclavicular with Inserter
07899258661599EXPERT FAST - SYNDESMOSIS - Flexible Knotless Fixator for Syndesmosis with Inserter
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.