RIGIDLOOP Multilig Adjustable Cortical Button 292004

GUDID 03760304680502

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 Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID03760304680502
NIH Device Record Keyd3f4a2a2-3cab-4e04-adc2-01c9415012e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIGIDLOOP Multilig Adjustable Cortical Button
Version Model NumberNON STERILE SAMPLE - NOT FOR IMPLANTATION
Catalog Number292004
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
GS103760304680502 [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

03760154002486 - LIGAFIX2023-12-29 Lanceolate eyelet pin Ø 2.5 mm - L 360 mm X5 to be used with LIGAFIX interference screws for ACL reconstruction.
03760154002493 - LIGAFIX2023-12-29 Lanceolate eyelet pin Ø 2.5 mm - L 360 mm X10 to be used with LIGAFIX interference screws for ACL reconstruction.
03760154002561 - LIGAFIX2023-12-29 Rigid guide pin Ø 0.9 mm - L 400 mm for screwdriver Ø 6-7-8 mm screws X5, for ACL reconstruction.
03760154002578 - LIGAFIX2023-12-29 Rigid guide pin Ø 0.9 mm - L 400 mm for screwdriver Ø 6-7-8 mm screws X10, for ACL reconstruction.
03760154002608 - LIGAFIX2023-12-29 Rigid guide pin Ø 1.4 mm - L 400 mm for screwdriver Ø 9-10-11 mm screws X5, for ACL reconstruction.
03760154002615 - LIGAFIX2023-12-29 Rigid guide pin Ø 1.4 mm - L 400 mm for screwdriver Ø 9-10-11 mm screws X10, for ACL reconstruction.
03760154002622 - LIGAFIX2023-12-29 Super elastic guide pin Ø 0.8 mm - L 300 mm for screwdriver Ø 6-7-8 mm screws X1, for ACL reconstruction.
03760154002639 - LIGAFIX2023-12-29 Super elastic guide pin Ø 0.8 mm - L 300 mm for screwdriver Ø 6-7-8 mm screws X5, for ACL reconstruction.
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