510(k) K240181
- Device
- Clavicle and Scapula System
- Applicant
- Auxein Medical Pvt., Ltd.
- 510(k) number
- K240181
- Product code
- HRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-10-09
- Date received
- 2024-01-23
- 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
- Gaurav Luthra
- Address
- Auxein Medical Pvt. Ltd. Plot # 168-169-170 Sector 57, Phase Iv, Hsiidc Kundli Sonepat IN 131028 131028
FDA Registration Numbers#
- 3011580264
- 1226544
- 3023265483
- 9614438
- 3007051929
- 3006801265
- 3010047402
- 3007993775
- 3013280419
- 3038503572
- 3014527928
- 3019923333
- 1058084
- 3010400367
- 9615766
- 3010470577
- 2032830
- 3004187715
- 3022777867
- 3021336182
- 2031009
- 3015869121
- 3011230048
- 3043543260
- 3011295718
- 3026576110
- 3010375065
- 3010646402
- 2531477
- 3036756245
- 3034676720
- 1218017
- 3010039400
- 3013540005
- 3011127597
- 1828288
- 1038671
- 3005751028
- 3027242374
- 3009756327
- 3016112537
- 3009882462
- 3010673777
- 3015978338
- 3006217744
- 1421101
- 3010120326
- 3007913880
- 3013176080
- 3007113169
- 2530808
- 2028632
- 3009423112
- 2183967
- 2030624
- 3027339877
- 3015869492
- 3010120135
- 3010363503
- 2320767
- 3017565094
- 3007109793
- 3017191784
- 3031240334
- 3014262693
- 3011302692
- 3010331645
- 1526439
- 1527105
- 3008337808
- 3027760323
- 3010220595
- 3011296511
- 3008599979
- 3012086398
- 3011354099
- 3008102042
- 3008791302
- 3004993707
- 2029275
Source Documents#
Other 510(k) Records For Product Code HRS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262779 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2026-10-23 |
| K263407 | Tempo Plating System | Pace Surgical | 2026-10-23 |
| 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 |