ADAPT For Gamma3

Orthopedic Stereotaxic Instrument

Stryker GmbH

The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for Adapt For Gamma3.

Pre-market Notification Details

Device IDK202749
510k NumberK202749
Device Name:ADAPT For Gamma3
ClassificationOrthopedic Stereotaxic Instrument
Applicant Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
ContactUgochi Okereke
CorrespondentUgochi Okereke
Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-21
Decision Date2020-12-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327512175 K202749 000
07613327512175 K202749 000
07613327512175 K202749 000
07613327512175 K202749 000
07613327512175 K202749 000
07613327512175 K202749 000
07613327512175 K202749 000
07613327512175 K202749 000
07613327512175 K202749 000
07613327512175 K202749 000
07613327512175 K202749 000
07613327512175 K202749 000
07613327512175 K202749 000
07613327512175 K202749 000

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