510(k) clearances

CraniUS Plate

CraniUS, LLC · Neurology

K262874Substantially EquivalentSpecialGWO
Open FDA's page for this record
Third party flag
N
City
Baltimore
Advisory committee description
Neurology
Address 1
1700 Union Ave., Suite A1
Statement or summary
Summary
Product code
GWO
Zip code
21211
Applicant
CraniUS, LLC
Decision date
2026-09-11
Decision code
SESE
Country code
US
Device name
CraniUS Plate
Advisory committee
NE
Contact
Sachin Thanawala
K number
K262874
State
MD
Date received
2026-08-14
Review advisory committee
NE
Postal code
21211
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Plate, Cranioplasty, Preformed, Alterable
Medical specialty description
Neurology
Regulation number
882.5320
Device class
2
Registration number
3015399803, 2027754, 1000606483, 3006017180, 3007738812, 3009424796, 8010177, 2530154, 2029275, 3004719693, 3015212339, 3009417901, 1649518, 1054811, 1724955, 9610905, 1057946, 1226425, 1032347, 2916714, 3003477135, 2249697, 3004464325, 3008791302, 3025141, 3008868758, 2027148, 3017884860, 1825034, 3008812560, 3004049923, 3007923096, 3011530718, 3034676720
FEI number
3015399803, 1000306431, 2027754, 3002807464, 1000606483, 3002821504, 3006017180, 3007738812, 3009424796, 3003018882, 3004719693, 3003142829, 3015212339, 3003070421, 3009417901, 1032347, 2916714, 3003477135, 1000114185, 3004464325, 1000307073, 3008791302, 3001236277, 3008868758, 2027148, 3017884860, 1825034, 3008812560, 1000525271, 3004049923, 3007923096, 3011530718, 1000125930, 3034676720
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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.