ORION ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K973854

Name: FDA 510(k) clearance K973854
Creator: U.S. Food and Drug Administration
Published: 1998-03-16

Substantially Equivalent for Some Indications

Sofamor Danek USA,Inc.

FDA 510(k) clearance K973854 for ORION ANTERIOR CERVICAL PLATE SYSTEM, Substantially Equivalent for Some Indications on 1998-03-16. Applicant: Sofamor Danek USA,Inc.. Device class: 2.

Clearance details

Applicant: Sofamor Danek USA,Inc.
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 1997-10-03
Decision date: 1998-03-16
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, 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 Sofamor Danek USA,Inc.

view all

K991031 — COLORADO II SPINAL SYSTEM2000-05-10
K984360 — COLORADO II SPINAL SYSTEM2000-03-30
K992928 — CD HORIZON SPINAL SYSTEM1999-09-21
K991036 — DANEK PLATE AND SCREW SYSTEM1999-09-14
K991198 — DYNA-LOK PLUS SPINAL SYSTEM1999-08-27

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.