DeviceClearance

Insignia Anterior Cervical Plate System— 510(k) K200995

Substantially Equivalent

Alphatec Spine, Inc.

FDA 510(k) clearance K200995 for Insignia Anterior Cervical Plate System, Substantially Equivalent on 2020-05-21. Applicant: Alphatec Spine, Inc.. Device class: 2.

Clearance details

Applicant
Alphatec Spine, Inc.
Product code
Code KWQ
Device class
Class 2
Regulation
21 CFR 888.3060
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carlsnad, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KWQ

product code KWQ
Death
8
Injury
1,212
Malfunction
1,233
Total
2,453

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K200995

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200995.

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