RIGIDLOOP BTB Adjustable Cortical Button 292005

GUDID 03760304680519

The RIGIDLOOP adjustable juxtacortical fixation device consists of an adjustable nonabsorbable braided loop and titanium button, preloaded with traction threads, designed to be used for ACL reconstruction. THE SAMPLE IS NON-STERILE, NOT INTENDED FOR IMPLANTATION.

S.B.M

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID03760304680519
NIH Device Record Key7bc549cc-e749-4a5a-b518-ac88f92182d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIGIDLOOP BTB Adjustable Cortical Button
Version Model NumberNON STERILE SAMPLE - NOT FOR IMPLANTATION
Catalog Number292005
Company DUNS772462123
Company NameS.B.M
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com
Phone574-404-8348
Emailerin.combs@its.jnj.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103760304680519 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-02
Device Publish Date2021-02-22

Devices Manufactured by S.B.M

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03760304681080 - SBM2024-07-03 Complete instrumentation tray composed of reusable surgical instruments for extremity surgery.
03760304681318 - SBM2024-07-03 250 x 250 sterilization basket lid
03760304681325 - SBM2024-07-03 250 x 250 sterilization basket with silicone mat
03760154001069 - OTIS-C-PLUS2024-06-28 Depth gauge for HTO.
03760154005685 - LIGAFIX2024-06-28 Chondral pick for ACL reconstruction.
03760154008167 - OTIS-F2024-06-28 Handle for the OTIS-F AO drill guide
03760154008174 - OTIS-F2024-06-28 AO drill guide
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