DORSAL NAIL PLATE, ANATOMICAL— 510(k) K052248

Clearance details

Applicant

Hand Innovations, LLC

Product code

Code HRS

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2005-08-18

Decision date

2005-09-14

Decision

Substantially Equivalent

Clearance type

Special

Location

Miami Lakes, FL, US

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• K261511 — Xpert Ankle2026-07-28

• K061748 — FRAGMENT PLATE SYSTEM2006-07-17
• K060864 — MULTIDIRECTIONAL THREADED PEG2006-04-28
• K060294 — DIAPHYSEAL PLATE2006-03-22
• K060290 — SHOULDER FIXATION SYSTEM2006-02-27
• K052294 — SHOULDER NAIL PLATE2005-10-21

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 →

• Z-2212-2014 — Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581Class II·Terminated·Biomet, Inc.·20140623

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052248.