ABC 2 SCREW— 510(k) K050813

Name: FDA 510(k) clearance K050813
Creator: U.S. Food and Drug Administration
Published: 2005-05-04

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K050813 for ABC 2 SCREW, Substantially Equivalent on 2005-05-04. Applicant: Aesculap, Inc.. Device class: 2.

Clearance details

Applicant: Aesculap, Inc.
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2005-03-31
Decision date: 2005-05-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWQ

view all

K261309 — Palisades Buttress Plate System2026-07-16
K252776 — ARIES Anterior Cervical Plate Systems2026-05-14
K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
K260570 — corra cervical plating system2026-04-22
K260697 — VyPlate Anterior Cervical Plate System2026-03-27

More clearances from Aesculap, Inc.

view all

K242762 — Aesculap Aicon® Series Container System2025-05-13
K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set2024-12-16
K223596 — SQ.line KERRISON2023-06-29
K214041 — Aesculap AICON Container2022-12-30
K211572 — Aesculap Slim Clip Applier2021-12-13

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.