510(k) K250055
- Device
- BPS - Bone Fragment Fixation Plates, Screws and Washers
- Applicant
- Orthonovis, Inc.
- 510(k) number
- K250055
- Product code
- HRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-06
- Date received
- 2025-01-10
- 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
Applicant Contact#
- Contact
- Ken West
- Address
- 1 Hargrove Grade Suite 2f Palm Coast FL US 32137 32137
FDA Registration Numbers#
- 2031009
- 3014937101
- 3004499989
- 3015806723
- 9614438
- 1526534
- 3010197224
- 3007109793
- 2320767
- 9681465
- 3005641619
- 3010120339
- 2183449
- 9611390
- 3017609305
- 3006849754
- 3008696586
- 3004635447
- 2532027
- 3015877656
- 9611112
- 3008114965
- 3010155648
- 8031010
- 9610726
- 3006001176
- 3014262693
- 3016851379
- 3005827567
- 1038671
- 3009513193
- 1054811
- 3005751028
- 3004941535
- 3008793310
- 3017528621
- 3007113169
- 9680825
- 3011656326
- 2530808
- 3025141
- 3032588003
- 3021010222
- 9610622
- 3010329663
- 3030926959
- 3021008900
- 3000327445
- 3009532798
- 3011301313
- 3038503932
- 3013011598
- 3006742481
- 3013413393
- 9613369
- 3010303097
- 9613910
- 3029933740
- 1828288
- 9613350
- 3012966183
- 3014207283
- 3002907620
- 3006513362
- 3010123206
- 3009882462
- 3009144915
- 3007366790
- 3004142400
- 3016084569
- 9615800
- 3023852420
- 8031020
- 3015946784
- 3010502940
- 1030489
- 3010173425
- 3009971621
- 3017565094
Source Documents#
Other 510(k) Records For Product Code HRS#
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|---|---|---|---|
| K260761 | APTUS Clavicle System 2.8 | Medartis AG | 2026-06-05 |
| K261002 | Pectus Blu System | Biomet Microfixation | 2026-06-02 |
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| K260323 | OrthoPediatrics® Locking Cannulated Blade Plate System | OrthoPediatrics Corp. | 2026-04-30 |
| K260411 | PC Fix System | Chest Wall Innovations, Inc. | 2026-04-24 |
| K260228 | POYA 3.5mm Medial Proximal Tibia System | Bonebridge AG | 2026-04-24 |
| K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | 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 |
| K260274 | Airlock® Ankle Plating System | Novastep SAS | 2026-03-25 |
| K254253 | LOQTEQ® VA Proximal Humerus Plate 3.5 | Aap Implantate AG | 2026-03-24 |
| K254288 | Clavicle Fixation System | Skeletal Dynamics, Inc. | 2026-03-23 |
| K260448 | CastleLoc Pectus Bar System | L&K BIOMED Co., Ltd. | 2026-03-19 |