510(k) clearances

Innovasis Navigation Instruments

Innovasis, Inc. · Neurology

K250182Substantially EquivalentTraditionalOLO
Open FDA's page for this record
Third party flag
N
City
Salt Lake City
Advisory committee description
Neurology
Address 1
614 E 3900 S
Statement or summary
Summary
Product code
OLO
Zip code
84107
Applicant
Innovasis, Inc.
Decision date
2025-03-24
Decision code
SESE
Country code
US
Device name
Innovasis Navigation Instruments
Advisory committee
NE
Contact
Michael Thomas
K number
K250182
State
UT
Date received
2025-01-22
Review advisory committee
OR
Postal code
84107
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Orthopedic Stereotaxic Instrument
Medical specialty description
Neurology
Regulation number
882.4560
Device class
2
Registration number
3027153110, 9617297, 1226544, 2027487, 3009493875, 3010047402, 3007993775, 3007485169, 1314417, 3010009632, 3003139373, 3006846753, 3009554293, 3009871135, 3005819474, 3006563559, 3004727093, 3015869121, 3043543260, 3026576110, 2531477, 3036756245, 3008027912, 3034676720, 1218017, 3006654680, 3010039400, 1828288, 3015941638, 3014680149, 3005751028, 3001284227, 3024999441, 3010822102, 1421101, 3016443334, 3010120326, 3004893332, 3021902355, 2530808 +350 more
FEI number
3027153110, 2027487, 3009493875, 3010047402, 3007993775, 1000139987, 3007485169, 1314417, 3007282753, 3010009632, 3003139373, 3002807231, 3006846753, 3009554293, 3009871135, 3005532635, 3005819474, 3006563559, 3003112432, 3004727093, 3008782585, 3015869121, 3043543260, 3026576110, 3002821504, 3002619595, 3036756245, 3008027912, 3034676720, 1218017, 3006654680, 3010039400, 1828288, 3005751028, 3014680149, 3001284227, 3024999441, 3010822102, 1421101, 3016443334 +350 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.