RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws— 510(k) K152256

Clearance details

Applicant

Normed Medizin-Technik GmbH

Product code

Code HRS

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2015-08-10

Decision date

2015-11-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tuttlingen, DE

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• K151708 — RECON system - Compression Screws2016-03-02
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• K152312 — RECON system-V-TEK-IVP Plates and Screws2015-10-30
• K152142 — RECON system - MPJ-Plates2015-09-16
• K151407 — RECON system2015-08-12

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 →