Array Guide 109101

GUDID M9461091010

THINK SURGICAL, INC.

Joint prosthesis implantation kit, reusable
Primary Device IDM9461091010
NIH Device Record Key4a1ee438-7b3b-4b6e-938e-86c6e67e06a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameArray Guide
Version Model Number109101
Catalog Number109101
Company DUNS007211430
Company NameTHINK SURGICAL, INC.
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 Usefalse
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(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com
Phone+1(510)249-2300
Emailcustomerservice@thinksurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM9461091010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


[M9461091010]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-05
Device Publish Date2023-08-28

Devices Manufactured by THINK SURGICAL, INC.

M946109900A1 - TMINI™ Guide Block Kit for Enovis™ EMPOWR Knee System®(10ea)2025-05-02
M946109900B1 - TMINI® Guide Block Kit for Total Joint Orthopedics Klassic® Knee System (10ea)2025-05-02
M946109900C1 - TMINI® Guide Block Kit for Ortho Development® Balanced Knee® (10ea)2025-05-02
M946109900D1 - TMINI® Guide Block Kit for United® U2™ Knee (10ea)2025-05-02
M946109900E1 - TMINI® Guide Block Kit for Medacta® Knee System (10ea)2025-05-02
M946109900F1 - TMINI® Guide Block Kit for b-ONE MOBIO® Total Knee System (10ea)2025-05-02
M946109900G1 - TMINI® Guide Block Kit for LINK® LinkSymphoKnee System (10ea)2025-05-02
M946109900J1 - TMINI® Guide Block Kit for Maxx Ortho Freedom® Total & Titan Knee (10ea)2025-05-02

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