221017

GUDID 10886705007455

Spiked Washer 17mm

DEPUY MITEK, LLC

Orthopaedic bone washer, non-sterile
Primary Device ID10886705007455
NIH Device Record Key71caee17-337e-4c29-bc6c-2429c91540ce
Commercial Distribution StatusIn Commercial Distribution
Version Model Number221017
Catalog Number221017
Company DUNS190572854
Company NameDEPUY MITEK, LLC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110886705007455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPIN, FIXATION, THREADED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


[10886705007455]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-08-30
Device Publish Date2015-09-01

Devices Manufactured by DEPUY MITEK, LLC

20886705000903 - NA2025-09-29 SuperAnchor Threader Tab
10886705000951 - NA2025-09-29 SuperAnchor Threader Tab
10886705001088 - LUPINE ETHIBOND2025-09-29 LUPINE Loop PLUS Anchor w/ETHIBOND PLA Absorbable Anchor, size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (
10886705001958 - QUICKANCHOR PANACRYL2025-09-29 Rotator Cuff QUICKANCHOR Plus Size 2 (5 metric) PANACRYL braided absorbable suture 36 Inches (91cm), with CP-2 needles, with dis
10886705001989 - GII QUICKANCHOR PANACRYL2025-09-29 GII QUICKANCHOR Plus Size 2 (5 metric) PANACRYL braided absorbable suture 36 Inches (91cm), double armed with CP-2 needles, with
10886705001996 - QUICKANCHOR PANACRYL2025-09-29 Super QUICKANCHOR Plus Size 2 (5 metric) PANACRYL braided absorbable suture 36 Inches (91cm), double armed with CP-2 needles, wi
10886705002047 - ETHIBOND2025-09-29 Rotator Cuff EasyAnchor Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), with disposable inserter
20886705002051 - ETHIBOND2025-09-29 Rotator Cuff EasyAnchor Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), with disposable inserter

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