510(k) clearances

Drill Guide; Drill Bit; Spine & Trauma Navigation

Brainlab AG · Neurology

K240701Substantially EquivalentSpecialOLO
Open FDA's page for this record
Third party flag
N
City
Munich
Advisory committee description
Neurology
Address 1
Olof-Palme-Str 9
Statement or summary
Summary
Product code
OLO
Zip code
81829
Applicant
Brainlab AG
Decision date
2024-05-23
Decision code
SESE
Country code
DE
Device name
Drill Guide; Drill Bit; Spine & Trauma Navigation
Advisory committee
NE
Contact
Esther Moreno Garcia
K number
K240701
Date received
2024-03-14
Review advisory committee
OR
Postal code
81829
Decision description
Substantially Equivalent
Clearance type
Special
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.