510(k) K261830
- Device
- 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)
- Applicant
- Ortler Global Tibbi Gerecler Anonim Sirketi
- 510(k) number
- K261830
- Product code
- HRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-28
- Date received
- 2026-06-02
- 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
- N
Applicant Contact#
- Contact
- TAHA CIBIR
- Address
- Ivedikkoy Mah., 1492 Cadde, 17 B, 43, Yenimahalle Ankara TR 06378 06378
FDA Registration Numbers#
- 3010041430
- 1057425
- 8031020
- 3009971621
- 3006946279
- 8010665
- 3018080016
- 3013820441
- 3015440604
- 1032347
- 1030489
- 1835251
- 1834331
- 9611281
- 3004638532
- 1043534
- 3005827567
- 3015869121
- 2183946
- 3010329663
- 3011530718
- 3015231789
- 1835444
- 3021349259
- 3004369035
- 2029447
- 3009189869
- 1000461041
- 3005706667
- 3003249380
- 9610622
- 3009882462
- 3008102042
- 2244478
- 3030691054
- 3016261131
- 3006179046
- 2183650
- 1424434
- 3002907620
- 3010726901
- 3034676720
- 3003935342
- 3004976965
- 3009756327
- 3034532468
- 3017980266
- 2242056
- 3013540005
- 1833920
- 3005562917
- 3009153862
- 3005751028
- 9680825
- 3014937101
- 3009513193
- 3013561205
- 3005004799
- 3033509898
- 3010606097
- 8043862
- 3023808054
- 3000170817
- 9611390
- 2531477
- 3025603301
- 3008747271
- 3009973699
- 3011623994
- 3003541440
- 3010047402
- 3014314623
- 3007143290
- 3021010222
- 1818910
- 8010099
- 1833986
- 3015974593
- 3008658204
- 3008599979
Source Documents#
Other 510(k) Records For Product Code HRS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |