FDA.report

S.M.A.I.O

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30153838643015383864S.M.A.I.O1N2026-01-012 Place Berthe Morisot Parc Technologique SAINT-PRIEST Auvergne-Rhone-Alpes FR 69800

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2794741161575230K253990KHEIRON® Spinal Fixation System, including patient specific K-RODNKB2026-01-07
2794741067069107K253721KHEIRON® Spinal Fixation System, including patient specific K-RODNKB2025-12-17
2794741661467698K251804KHEIRON® Spinal Fixation System, including patient specific K-RODNKB2025-07-08
2794741943635789K223841KBA3DLLZ2023-05-30
2794741593904357K213975KEOPS Balance Analyzer 3DLLZ2022-05-06
2794742052623662K211981KHEIRON® Spinal Fixation SystemNKB2022-06-09
2794741789651137K211414KHEIRON Spinal Fixation SystemNKB2021-08-10
2794742022274958K201659KHEIRON® Spinal Fixation SystemNKB2020-10-05
2794741020838467
2794741060871270
2794741116740053
2794741121577845
2794741177534793
2794741183712657
2794741478085731
2794741526728784
2794741530289815
2794741732083936
2794741732274155
2794741817441235
2794741972736110
2794741986661295
2794742002973728
2794742060680260

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
NKB62026-01-07
LLZ22023-05-30

PMN

GUDID

200 records. Showing 1-40. Next