Device classification

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Orthopedic · 21 CFR 888.3030

Class IIProduct code LXT
Open FDA's page for this record
Third party flag
N
Life sustain support flag
N
Gmp exempt flag
N
Summary malfunction reporting
Eligible
Product code
LXT
Review panel
OR
Medical specialty
OR
Device name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Medical specialty description
Orthopedic
Device class
2
Regulation number
888.3030
Implant flag
Y
Submission type ID
1
Harmonized identifiers (openFDA)
K number
K974245, K060290, K063832, K984357, K050932, K001760, K042458, K954053, K230067, K031959, K003240, K000957, K032705, K960269, K000558, K031973, K002923, K003205, K991407, K052754, K042059, K990848, K013739, K032169, K962846, K090374, K051306, K003211, K991889, K864403, K050631, K000972, K131636, K031428, K963432, K963618, K950384, K013772, K033145, K033805 +17 more
Registration number
3010462278, 1526439, 3009546990, 3014302784, 1644408, 3015440604, 2245304, 3033509898, 3025603301, 3004748528, 3005497913, 1828288, 3034676720, 3043355196, 3010120326, 3005061536, 1526534, 1833920, 3004049923, 1222773, 2183744, 3006015326, 3006694268, 3015869492, 3010120104, 3010158639, 2437731, 9680825, 3003108161, 2183449, 3019767615, 3003525643, 3015399803, 3015542154, 3010287687, 3006946279, 3007738812, 3009417901, 3011683674, 3008534770 +59 more
FEI number
3002807648, 3010462278, 1526439, 3009546990, 3014302784, 3015440604, 2245304, 3033509898, 3025603301, 1000125930, 3004748528, 3005497913, 1828288, 3034676720, 3043355196, 3001452082, 3010120326, 3005061536, 1526534, 3004049923, 2183744, 3006015326, 3006694268, 3015869492, 3002926812, 3010120104, 3010158639, 1000116912, 3003108161, 2183449, 3001814066, 3019767615, 3003525643, 1000306340, 3015399803, 3015542154, 3010287687, 3006946279, 3007738812, 3009417901 +59 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

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.