intellijoint KNEE(R)

GUDID 00628184519004

Bone Screw

Intellijoint Surgical Inc

Orthopaedic stereotactic surgery system
Primary Device ID00628184519004
NIH Device Record Key8c9de0c1-59a9-4b65-a7e1-6f7507ffdbb7
Commercial Distribution StatusIn Commercial Distribution
Brand Nameintellijoint KNEE(R)
Version Model Number000-0519
Company DUNS202958070
Company NameIntellijoint Surgical Inc
Device Count2
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone15193423178
Emailinfo@intellijointsurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100628184519004 [Primary]
GS190628184005197 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00628184519004]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-09
Device Publish Date2019-12-06

Devices Manufactured by Intellijoint Surgical Inc

00628184005668 - intellijoint KNEE®2022-01-18 Rotational Sizer Interface
00628184005590 - intellijoint KNEE®2021-03-02 Probe Adaptor 1.3 - 1.4mm
00628184005606 - intellijoint KNEE®2021-03-02 Probe Adaptor 1.5 - 1.6mm
00628184005613 - intellijoint KNEE®2021-03-02 Probe Adaptor 1.7 - 1.8mm
00628184002810 - intellijoint navigation system2020-07-15 Camera, USB, G2
00628184004012 - intellijoint HIP®2020-07-15 Angled Probe
00628184003930 - intellijoint HIP®2020-06-17 Pelvic Platform, Mini
00628184002704 - intellijoint HIP®2020-04-01 Arm, Camera Mount, Magnetic Base

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