510(k) clearances

Versalock Proximal Tibial Plating System

GM Dos Reis Industria e Comercio Ltda. · Orthopedic

K261406Substantially EquivalentTraditionalHRS
Open FDA's page for this record
Third party flag
N
City
Campinas
Advisory committee description
Orthopedic
Address 1
Avenida Pierre Simon De Laplace, 600
Statement or summary
Summary
Product code
HRS
Zip code
13069320
Applicant
GM Dos Reis Industria e Comercio Ltda.
Decision date
2026-07-21
Decision code
SESE
Country code
BR
Device name
Versalock Proximal Tibial Plating System
Advisory committee
OR
Contact
Guilherme Esteves Pontes
K number
K261406
Date received
2026-04-29
Review advisory committee
OR
Postal code
13069320
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Plate, Fixation, Bone
Medical specialty description
Orthopedic
Regulation number
888.3030
Device class
2
Registration number
2249615, 3013176080, 3008951116, 9610921, 3006849754, 3013843055, 2029275, 9611274, 3010057495, 3012447612, 1835831, 3004635447, 3010123256, 3008285983, 1528646, 3009532798, 3023808054, 3031261833, 2032098, 3009998573, 3043026734, 1221051, 1424434, 3004049923, 3013540005, 3043543260, 3034525, 3009153862, 3004549189, 2024024, 3010673850, 3009540749, 3011656326, 9710629, 3012818475, 3015542154, 3009417901, 3016247852, 3005983700, 3022159082 +483 more
FEI number
3013176080, 3008951116, 3003056094, 3006849754, 3013843055, 1000116116, 3010057495, 3012447612, 3004635447, 3010123256, 3008285983, 3002459190, 3002807113, 3009532798, 3023808054, 3031261833, 1000136451, 3009998573, 3043026734, 1221051, 3003110073, 3004049923, 1000115656, 3013540005, 3002786339, 3043543260, 3009153862, 3000215273, 2024024, 3010673850, 3009540749, 3011656326, 3012818475, 3015542154, 3009417901, 5870, 3016247852, 3005983700, 3022159082, 3010440433 +483 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.