510(k) K173293
- Device
- EVOS Small Fragment Upper Extremity Plates
- Applicant
- Smith & Nephew, Inc.
- 510(k) number
- K173293
- Product code
- HRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-01-08
- Date received
- 2017-10-16
- 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
- Samantha Staubach
- Address
- 1450 Brooks Rd. Memphis TN US 38116 38116
FDA Registration Numbers#
- 3007648354
- 3003541440
- 1834379
- 3004142400
- 3027339877
- 3015212339
- 3008556682
- 1720929
- 3014763043
- 3017565094
- 9615800
- 3014129047
- 3010375065
- 3006783837
- 3005004799
- 3010173425
- 3005983700
- 3022142628
- 3008696586
- 3010370500
- 3009423112
- 2031009
- 3010123256
- 3006498370
- 3008749819
- 2183785
- 3011580264
- 3031800723
- 3006946279
- 3009631939
- 3009381600
- 2530808
- 3004371426
- 3000327445
- 3009513193
- 3015399803
- 2249529
- 3031240334
- 3043543260
- 3010462278
- 3030412764
- 3014314623
- 3010120326
- 3008650117
- 3013756169
- 2648666
- 3010049501
- 3010032903
- 1221053
- 3007109793
- 3010123206
- 8031020
- 3021393544
- 3017521423
- 3004993707
- 2133928
- 2024024
- 1835251
- 3011301313
- 3014655115
- 3010667733
- 3034532468
- 2027148
- 3025603301
- 3000170817
- 3002907620
- 3033519208
- 3006694268
- 3026576110
- 3016438694
- 3018080016
- 3011127597
- 3017209758
- 3021010222
- 3008534770
- 3010389204
- 1319660
- 1835831
- 3006017180
Source Documents#
Other 510(k) Records For Product Code HRS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary