OPTERYX ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K061147

Clearance details

Applicant

Innovasis, Inc.

Product code

Code KWQ

Device class

Class 2

Regulation

21 CFR 888.3060

Advisory panel

Orthopedic

Date received

2006-04-25

Decision date

2006-06-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Salt Lake City, UT, US

• 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

• K251073 — Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)2025-07-23
• K250182 — Innovasis Navigation Instruments2025-03-24
• K241276 — Vector Pedicle Screw System2024-05-20
• K231899 — HAtetracell-C Titanium Cervical IBF System2023-10-17
• K223511 — Excella Navigation Instruments2023-05-02

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 →

• Z-2153-2017 — Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx¿ Cervical Plate System is intended as a temporary fixation device used for correction and stabilization of the cervical spine. Variable angle screws are included to allow the physician greater flexibility when placing the plates and securing it to the vertebrae.Class II·Terminated·Innovasis, Inc·20170505

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061147.