SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D— 510(k) K121148

Name: FDA 510(k) clearance K121148
Creator: U.S. Food and Drug Administration
Published: 2012-08-20

Substantially Equivalent

Medical Design, LLC

FDA 510(k) clearance K121148 for SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D, Substantially Equivalent on 2012-08-20. Applicant: Medical Design, LLC. Device class: 2.

Clearance details

Applicant: Medical Design, LLC
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2012-04-16
Decision date: 2012-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sioux Falls, SD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HWC

view all

K261057 — ActivaScrew Cannulated COM2026-09-04
K260106 — OsteoCoil GT Active Compression System2026-08-24
K262344 — Large Compression Screws2026-08-12
K253858 — GFS - Sterile Screws and Top Hat2026-08-05
K262075 — Lapidus Screw Kit2026-07-22

More clearances from Medical Design, LLC

view all

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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 →

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