510(k) K153531
- Device
- Treace Medical Concepts (TMC) Plating System
- Applicant
- TREACE MEDICAL CONCEPTS, INC.
- 510(k) number
- K153531
- Product code
- HRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-01-07
- Date received
- 2015-12-09
- 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
- No
Applicant Contact#
- Contact
- JOE FERGUSON
- Address
- 3107 Sawgrass Village Cir. Ponte Vedra Beach FL US 32082 32082
FDA Registration Numbers#
- 3043620689
- 3014315560
- 9614438
- 3005497913
- 3011500362
- 3027339877
- 3010047454
- 3006639944
- 1226544
- 9681465
- 1833986
- 3009923578
- 3007113169
- 3006783837
- 2027148
- 3010120339
- 2183785
- 1000461041
- 3008559295
- 3019767615
- 3003477135
- 1060840
- 3027242374
- 3012447612
- 3006395932
- 3016084569
- 9610921
- 3007334927
- 3009971621
- 3015531529
- 1225838
- 3013055499
- 3017209758
- 3013820441
- 3008599979
- 3010068573
- 3017565094
- 9615766
- 3013767421
- 3038503932
- 3018094310
- 1226425
- 3011015572
- 3015869493
- 1061927
- 3038776593
- 2648920
- 3001239363
- 3003525643
- 3007441485
- 3010370500
- 3011683674
- 3010123206
- 3032588003
- 3010726901
- 3007051929
- 3029933740
- 1720929
- 1835296
- 3034532468
- 3003541440
- 3006791286
- 3006946279
- 1224360
- 3010470577
- 3004142400
- 3010118938
- 8031010
- 3016851379
- 1423662
- 3012966183
- 3016759112
- 3009887475
- 9615800
- 1313525
- 9611274
- 3006128100
- 3007366790
- 1319660
- 1828464
Source Documents#
Other 510(k) Records For Product Code HRS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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