GPS 02-521-90-0030

GUDID 10885862564825

External Tracker Fixator 30 Deg

Exactech, Inc.

Orthopaedic stereotactic surgery system

• Primary Device ID: 10885862564825
• NIH Device Record Key: 23e86f5f-d679-4ce4-89cb-b56469b7859d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GPS
• Version Model Number: 02-521-90-0030
• Catalog Number: 02-521-90-0030
• Company DUNS: 157565946
• Company Name: Exactech, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree
• Device Size Text, specify: 0
• Angle: 30 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862564825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100742

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10885862564825]

Moist Heat or Steam Sterilization

[10885862564825]

Moist Heat or Steam Sterilization

[10885862564825]

Moist Heat or Steam Sterilization

[10885862564825]

Moist Heat or Steam Sterilization

[10885862564825]

Moist Heat or Steam Sterilization

[10885862564825]

Moist Heat or Steam Sterilization

[10885862564825]

Moist Heat or Steam Sterilization

[10885862564825]

Moist Heat or Steam Sterilization

[10885862564825]

Moist Heat or Steam Sterilization

[10885862564825]

Moist Heat or Steam Sterilization

[10885862564825]

Moist Heat or Steam Sterilization

[10885862564825]

Moist Heat or Steam Sterilization

[10885862564825]

Moist Heat or Steam Sterilization

[10885862564825]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-26
• Device Publish Date: 2022-08-18

On-Brand Devices [GPS]

• 10885862606891: GPS GUIDE NO STYLUS
• 10885862564832: GPS TRU 3.5MM BALL HEX DRIVER ZHUDSON
• 10885862564801: GPS COLLARED 3.2MM DRILL RTG
• 10885862564788: GPS TRU FINISHING GUIDE PIN ADAPTOR
• 10885862564771: GPS TRU REAL TIME GUIDE COUPLER
• 10885862564757: GPS TRU REAL TIME GUIDE
• 10885862564740: GPS FEMORAL ADJUSTABLE RESECTION GUIDE
• 10885862564733: GPS RIGHT TIBIAL BASE
• 10885862564726: GPS RIGHT TIBIAL ADJUST RESECTION GUIDE
• 10885862564719: GPS LEFT TIBIAL BASE
• 10885862564702: GPS LEFT TIBIAL ADJUST RESECTION GUIDE
• 10885862542038: SHOULDER GPS IMPACTOR HANDLE
• 10885862527776: OFF SHLDR GPS BLOCK R
• 10885862527769: OFF SHLDR GPS BLOCK L
• 10885862319272: SHLDR GPS RVRS DRILL KIT
• 10885862319197: SHOULDR GPS HEX PINS KIT
• 10885862314338: SHLDR GPS CAN CNTR DRILL
• 10885862314321: SHOULDER GPS CNTR DRILL
• 10885862311238: GPS MINI TRAY LID
• 10885862310040: GPS MODIFIED TIBIAL CUTTING BLOCK UNCAPTURED
• 10885862310033: GPS MODIFIED TIBIAL CUTTING BLOCK
• 10885862308238: SHLDR GPS HUDSON ADAPTER
• 10885862308146: SHLDR GPS MODULAR DRIVER
• 10885862289018: GPS TRACKER TRAY TRACKERS ONLY
• 10885862289001: GPS LPI UPPER TRAY INSTRUMENT TRAY
• 10885862288998: GPS LPI GENERIC INSTRUMENT TRAY
• 10885862288981: GPS UPPER TRAY INSTRUMENT TRAY
• 10885862288974: GPS/LPI CORE INSTRUMENT TRAY
• 10885862288950: LID, GPS
• 10885862238160: INSTRUMENT TRAY, SLED, TENSOR, GPS
• 10885862238153: INSTRUMENT TRAY, SLED, FEMORAL, GPS 4-IN-1 POSITION GUIDE
• 10885862238146: INSTRUMENT TRAY, SLED, GPS, EXTERNAL TRACKER FIXATOR
• 10885862238139: INSTRUMENT TRAY, SLED, TIBIAL, GPS
• 10885862238122: INSTRUMENT TRAY, SLED, FEMORAL, GPS
• 10885862238115: GPS GENERIC SPACE SLED
• 10885862238108: INSTRUMENT TRAY, GPS
• 10885862092984: SLED, TIBIAL GPS BLOCK BASE, L&R
• 10885862092960: GPS SECONDARY MODULAR
• 10885862092953: GPS PRIMARY MODULAR SLED INSTRUMENT TRAY
• 10885862564825: External Tracker Fixator 30 Deg
• 10885862564818: External Tracker Fixator 0 Deg
• 10885862308184: SHOULDER GPS DRILL, 3.2mm
• 10885862308177: Shoulder GPS 2.9mm Drill Bit
• 10885862092830: SCREWDRIVER, HEX, DIAMETER 3.5mm
• 10885862539229: SHDLR GPS PEG DRL GD R16
• 10885862539212: SHDLR GPS PEG DRL GD L16
• 10885862539205: SHDLR GPS PEG DRL GD R 8
• 10885862539199: SHDLR GPS PEG DRL GD L 8
• 10885862539182: SHDLR GPS PEG DRL GD R
• 10885862539175: SHDLR GPS PEG DRL GD L