510(k) K233665
- Device
- DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System
- Applicant
- DePuy Synthes
- 510(k) number
- K233665
- Product code
- HRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-03-21
- Date received
- 2023-11-15
- Regulation
- 888.3030
- Classification name
- Plate, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jeffrey Krawiec
- Address
- 1301 Goshen Pkwy. West Chester PA US 19380 19380
FDA Registration Numbers#
- 3004369035
- 1935627
- 3006849754
- 3014967149
- 3003236702
- 3017565094
- 3008812560
- 3004049923
- 3012086398
- 1043534
- 3017191784
- 3010331645
- 3009116370
- 3007993775
- 3027339877
- 3010726901
- 3009882462
- 3006801265
- 9680619
- 3010362364
- 3019269298
- 3010509633
- 3038776593
- 2320767
- 3014262693
- 1835572
- 3013700547
- 3016759112
- 3014483751
- 3011388423
- 1424434
- 3016438694
- 3043026734
- 9680515
- 3010440433
- 3011296511
- 3012755988
- 3010120135
- 3003249380
- 3008868758
- 8031020
- 1828288
- 3026311512
- 9610921
- 1834331
- 3034525
- 3010041499
- 1057425
- 1222274
- 3043543260
- 3043620689
- 3019455
- 3009996260
- 2133928
- 3016084569
- 1824199
- 3030183061
- 3013846070
- 3004187715
- 3016727307
- 3016851379
- 3009513193
- 3008114965
- 3004217743
- 3000170817
- 1649518
- 1061927
- 3011623994
- 3008534770
- 3010009693
- 3012447612
- 3010041511
- 3015131017
- 3009417901
- 3010173425
- 3016778139
- 9611813
- 3005874553
- 2031009
- 8010944
Source Documents#
Other 510(k) Records For Product Code HRS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263269 | Park's Pectus System | Tdm Co., Ltd. | 2026-10-15 |
| K261611 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | 2026-10-02 |
| K262649 | Alians Forearm | Newclip Technics | 2026-09-28 |
| K261892 | ProRib Fixation System | Costa Surgical, Inc. | 2026-09-23 |
| K262098 | EnHAnce PEEK Bunion System | Nvision Biomedical Technologies | 2026-09-18 |
| K262963 | TMC Implant Fixation System | Treace Medical Concepts, Inc. | 2026-09-15 |
| K261647 | Tempo Plating System; Ultra Compression Screw System | Pace Surgical | 2026-09-03 |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) | Ortler Global Tibbi Gerecler Anonim Sirketi | 2026-08-28 |
| K262537 | Versalock Sterile Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-08-19 |
| K260277 | MIKRON TRAUMA BONE PLATE& SCREW SYSTEM | Mikron Makina San. ve Tic. Ltd. Sti. | 2026-08-13 |
| K261511 | Xpert Ankle | Newclip Technics | 2026-07-28 |
| K261406 | Versalock Proximal Tibial Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-07-21 |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) | TriMed, Inc. | 2026-07-16 |
| K261191 | Alians Elbow S | Newclip Technics | 2026-07-08 |
| K261054 | RibPlate System | Stryker Leibinger GmbH & Co KG | 2026-07-01 |