510(k) K243469
- Device
- SIGNEX
- Applicant
- Osteonic Co., Ltd.
- 510(k) number
- K243469
- Product code
- HRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-29
- Date received
- 2024-11-08
- 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
- Hye-Min Ahn
- Address
- 405ho, 505-2ho, 505-3ho, 508ho, 902ho, 1004ho, 1201ho, 1202ho, 1206ho 38 Digital-Ro 29-Gil, Guro-Gu Seoul KR 08381 08381
FDA Registration Numbers#
- 3010097171
- 3014302784
- 3001239363
- 1424263
- 3005004799
- 3011530718
- 3015869492
- 3023265483
- 9613910
- 3010440433
- 3007143290
- 3017609305
- 9615800
- 3017521423
- 3023808054
- 3010178296
- 3006513362
- 3026311512
- 3010118938
- 3016247852
- 3016261131
- 3008102042
- 2532027
- 3009144915
- 3002807295
- 3012086398
- 3007113169
- 1833920
- 3010057495
- 1319660
- 1835296
- 3013014058
- 1649390
- 3011187779
- 3009662565
- 3010041511
- 3013176080
- 3015542154
- 3018080016
- 3015531529
- 3006498370
- 3027339877
- 3012329926
- 3014170143
- 1835572
- 1000517406
- 2031009
- 3008599979
- 3009887475
- 3024890263
- 3009732568
- 3015410662
- 1833986
- 3010049501
- 3009888740
- 3016112537
- 2030624
- 3010389204
- 3010462278
- 3011015572
- 3004976965
- 3006639944
- 1720929
- 3010667733
- 3004217743
- 3010329663
- 3017980266
- 3010120339
- 3017435639
- 9611813
- 2320767
- 3010726901
- 3007648354
- 9710629
- 1828288
- 3011296511
- 1038671
- 3014314623
- 1526711
Source Documents#
Other 510(k) Records For Product Code HRS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261054 | RibPlate System | Stryker Leibinger GmbH & Co KG | 2026-07-01 |
| K261351 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | 2026-06-26 |
| K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L | I.T.S. GmbH | 2026-06-16 |
| K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | 2026-06-12 |
| K260761 | APTUS Clavicle System 2.8 | Medartis AG | 2026-06-05 |
| K261002 | Pectus Blu System | Biomet Microfixation | 2026-06-02 |
| K261038 | Xpert PFP | Newclip Technics | 2026-05-29 |
| K261145 | Avanti Distal Elbow ORIF System | Avanti Orthopaedics, LLC | 2026-05-09 |
| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | OrthoPediatrics Corp. | 2026-04-30 |
| K260411 | PC Fix System | Chest Wall Innovations, Inc. | 2026-04-24 |
| K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | 2026-04-24 |
| K260228 | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | 2026-04-24 |
| K260090 | SMART Osteotomy System | Actis Medical Pty., Ltd. | 2026-04-10 |
| K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | 2026-04-01 |
| K260291 | Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc. | 2026-03-25 |