510(k) K231684
- Device
- Quick - Radius Disposable Set
- Applicant
- GM Dos Reis Industria e Comercio Ltda.
- 510(k) number
- K231684
- Product code
- HRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-01-12
- Date received
- 2023-06-09
- Regulation
- 888.3030
- Classification name
- Plate, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Guilherme Esteves Pontes
- Address
- Avenida Pierre Simon De La Pl. 600 Campinas BR 13069-320 13069-320
FDA Registration Numbers
- 1450662
- 3016778139
- 9680619
- 3030926959
- 3023808054
- 1649390
- 3015131017
- 1043534
- 3004464325
- 3001239363
- 1421101
- 3012086398
- 3023852420
- 1834331
- 3003541440
- 3013756169
- 3015075784
- 3005290844
- 3013194153
- 1833824
- 1313525
- 3015410662
- 1643264
- 3000170817
- 1319660
- 9611579
- 3017521423
- 2028523
- 3027339877
- 3002949614
- 9612277
- 3009756327
- 8010177
- 3010846112
- 2249697
- 3010863450
- 3019767615
- 3010331645
- 1531050
- 3008696586
- 3006128100
- 1225838
- 3002962587
- 3007648354
- 3010118938
- 1030489
- 3012478585
- 3017609305
- 3029933740
- 3017191784
- 2183449
- 2183967
- 1060840
- 3006001176
- 3005751028
- 3002807295
- 3009196021
- 1061927
- 3009189869
- 3009887475
- 9616680
- 1221053
- 3010047454
- 3016247852
- 3014315669
- 3009973505
- 8030965
- 3016761372
- 3012447612
- 3021336182
- 9610622
- 3006017180
- 3016237080
- 1835296
- 3009153862
- 1032347
- 3008599979
- 2029275
- 9615128
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07899258659558 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659633 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659626 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659619 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659602 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659596 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659589 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659572 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659565 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659640 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659541 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659534 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659527 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659510 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659503 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659497 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659480 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659800 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659657 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659664 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659671 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659688 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659695 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659701 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659718 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659725 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659732 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659749 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659756 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
| 07899258659763 | Quick - Radius Disposable Set | GM DOS REIS INDUSTRIA E COMERCIO LTDA | 2024-01-26 |
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| K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | 2026-04-01 |
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| K254288 | Clavicle Fixation System | Skeletal Dynamics, Inc. | 2026-03-23 |
| K260448 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2026-03-19 |
| K260390 | Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-03-17 |
| K254053 | APS Spear Locking Plate | A Plus Biotechnology Co., Ltd. | 2026-03-17 |
| K253916 | APTUS Shoulder Proximal Humerus System, PentaLock 3.5 | Medartis AG | 2026-03-16 |