EXACTECHGPS L00041

GUDID 10885862518767

SOFTWARE APPLICATION, TOTAL SHOULDER PLANNING

Exactech, Inc.

Robotic surgical navigation system
Primary Device ID10885862518767
NIH Device Record Key7ac530d1-a25c-4221-b882-d1330688de26
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXACTECHGPS
Version Model NumberL00041
Catalog NumberL00041
Company DUNS157565946
Company NameExactech, Inc.
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110885862518767 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2026-03-19
Device Publish Date2017-12-18

On-Brand Devices [EXACTECHGPS]

10885862607195Diamond Tracker2 G
10885862607188Diamond Tracker2 T
10885862607171Diamond Tracker2 F
10885862607164Probe Tracker2 P
10885862625601Mounting Arm – Upper Part 4 positions
10885862632715Station V3 Disposable Kit
10885862628961Station V3 Carrying Case
10885862628954Station V3 Power Supply
10885862628947Station V3
10885862635402Glenoid Baseplate Inserter Handle
10885862574091STATION2+
10885862553331MOBILE CART
10885862518927MOUNTING ARM
10885862518767SOFTWARE APPLICATION, TOTAL SHOULDER PLANNING
10885862266675TRAVEL CASE
10885862266668POWER SUPPLY
10885862266651IMPLANT KIT
10885862252821STATION
10885862144294IMPLANT KIT
10885862144287TRACKER
10885862144270TRACKER
10885862144263TRACKER
10885862144256PROBE
10885862144225POWER CABLE
10885862144218MOUNTING ARM CLAMP
10885862144195MOUNTING ARM

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.