C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM— 510(k) K080646
Substantially EquivalentBiomet Spine
FDA 510(k) clearance K080646 for C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM, Substantially Equivalent on 2008-05-02. Applicant: Biomet Spine. Device class: 2.
Clearance details
- Applicant
- Biomet Spine
- 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
- Parsippany, NJ, US
Recent devices under product code KWQ
view allMore clearances from Biomet Spine
view allAdverse 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 K080646
K-number listed on FDA's recall record- Z-0203-2016 — MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.
- Z-2744-2015 — Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080646.
Data sourced from openFDA. This site is unofficial and independent of the FDA.