510(k) clearances

Trigon Trigon HA Stand-Alone Wedge Fixation System

Nvision Biomedical Technologies · Orthopedic

K234116Substantially EquivalentSpecialPLF
Open FDA's page for this record
Third party flag
N
City
San Antonio
Advisory committee description
Orthopedic
Address 1
4590 Lockhill Selma
Statement or summary
Summary
Product code
PLF
Zip code
78249
Applicant
Nvision Biomedical Technologies
Decision date
2024-01-26
Decision code
SESE
Country code
US
Device name
Trigon Trigon HA Stand-Alone Wedge Fixation System
Advisory committee
OR
Contact
Analaura Villarreal Berain
K number
K234116
State
TX
Date received
2023-12-27
Review advisory committee
OR
Postal code
78249
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Bone Wedge
Medical specialty description
Orthopedic
Regulation number
888.3030
Device class
2
Registration number
1526534, 3009540749, 3014833750, 3027339877, 3036718423, 1833506, 3010123256, 1054811, 3017980495, 3014655115, 3011301313, 3013194153, 3009923578, 3002807112, 3009826895, 1220246, 3003236702, 1423662, 3016851379, 3008650117, 1720929, 3017597868, 2027062, 3012966183, 1319660, 3003477135, 3015806723, 3009973336, 3010331645, 3015231789, 2245304, 3019269298, 1935627, 3005032068, 3010400367, 3020704423, 3025602479, 3009513193, 3014004349, 3030271054 +1 more
FEI number
1526534, 3009540749, 3014833750, 3027339877, 3036718423, 3010123256, 3017980495, 3014655115, 3011301313, 3013194153, 1000136478, 3009923578, 3002807112, 1832656, 3000215273, 3009826895, 1220246, 3003236702, 3016851379, 3008650117, 1720929, 3017597868, 2027062, 3012966183, 3003477135, 3015806723, 3009973336, 3010331645, 3015231789, 2245304, 1000114185, 3019269298, 1935627, 3005032068, 3010400367, 3020704423, 3025602479, 3009513193, 3014004349, 3030271054 +1 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.