LACTOSORB RAPIDFLAP— 510(k) K003281

Clearance details

Applicant

Biomet, Inc.

Product code

Code JEY

Device class

Class 2

Regulation

21 CFR 872.4760

Advisory panel

Dental

Date received

2000-10-19

Decision date

2001-08-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

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• K253434 — OSSTM Orthopedic Salvage System2026-07-01
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• K241014 — Biomet Kirschner Wires (K-Wires)2024-05-22
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• K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15

Injury

1,542

Malfunction

2,292

Total

3,834

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-1705-2018 — Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.Class II·Terminated·Zimmer Biomet, Inc.·20180405

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K003281.