EVOS MINI-FRAGMENT PLATING SYSTEM— 510(k) K140814
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K140814 for EVOS MINI-FRAGMENT PLATING SYSTEM, Substantially Equivalent on 2014-05-07. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Memphis, TN, US
Recent devices under product code HRS
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- K254084 — AETOS Shoulder System - CONCELOC Glenoids
- K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0
Adverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K140814
K-number listed on FDA's recall record- Z-2945-2020 — EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments.
- Z-0408-2018 — smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from the EVOS Mini-Fragment Plating System are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140814.
Data sourced from openFDA. This site is unofficial and independent of the FDA.