CHARLOTTE CLAW PLATE SYSTEM— 510(k) K133715

Name: FDA 510(k) clearance K133715
Creator: U.S. Food and Drug Administration
Published: 2014-02-28

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K133715 for CHARLOTTE CLAW PLATE SYSTEM, Substantially Equivalent on 2014-02-28. Applicant: Wrightmedicaltechnologyinc. Device class: 2.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2013-12-05
Decision date: 2014-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

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K262537 — Versalock Sterile Plating System2026-08-19
K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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 K133715

K-number listed on FDA's recall record

Z-2599-2014 — CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON STERILE OrthopedicClass II·Terminated·Wright Medical Technology, Inc.·20140730
Z-2600-2014 — CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF 4013-0130, 1 EACH, Rx ONLY, NON STERILE OrthopedicClass II·Terminated·Wright Medical Technology, Inc.·20140730
Z-2601-2014 — CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE OrthopedicClass II·Terminated·Wright Medical Technology, Inc.·20140730
Z-2602-2014 — CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE OrthopedicClass II·Terminated·Wright Medical Technology, Inc.·20140730
Z-2603-2014 — CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONLY, NON STERILE OrthopedicClass II·Terminated·Wright Medical Technology, Inc.·20140730
Z-2604-2014 — CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE OrthopedicClass II·Terminated·Wright Medical Technology, Inc.·20140730
Z-2605-2014 — CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EACH, Rx ONLY, NON STERILE OrthopedicClass II·Terminated·Wright Medical Technology, Inc.·20140730
Z-2607-2014 — CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EACH, Rx ONLY, NON STERILE OrthopedicClass II·Terminated·Wright Medical Technology, Inc.·20140730
Z-2608-2014 — CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY, NON STERILE OrthopedicClass II·Terminated·Wright Medical Technology, Inc.·20140730

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133715.

Data sourced from openFDA. This site is unofficial and independent of the FDA.