Integrity Implants Navigated Instruments

Orthopedic Stereotaxic Instrument

Integrity Implants Inc.

The following data is part of a premarket notification filed by Integrity Implants Inc. with the FDA for Integrity Implants Navigated Instruments.

Pre-market Notification Details

Device IDK212088
510k NumberK212088
Device Name:Integrity Implants Navigated Instruments
ClassificationOrthopedic Stereotaxic Instrument
Applicant Integrity Implants Inc. 354 Hiatt Drive Palm Beach Gardens,  FL  33418
ContactLauren Kamer
CorrespondentRoshana Ahmed
TELOS Partners, LLC 571 Christina Lake Drive Lakeland,  FL  33813
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-06
Decision Date2021-12-23

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