MSD BIPOLAR FORCEPS— 510(k) K061635
Substantially EquivalentMedtronic Sofamor Danek
FDA 510(k) clearance K061635 for MSD BIPOLAR FORCEPS, Substantially Equivalent on 2006-09-05. Applicant: Medtronic Sofamor Danek. Device class: 2.
Clearance details
- Applicant
- Medtronic Sofamor Danek
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Recent devices under product code GEI
view allMore clearances from Medtronic Sofamor Danek
view all- K212428 — Centerpiece Plate Fixation System
- K201267 — Adaptix Interbody System with Titan nanoLOCK Surface Technology
- K173125 — T2 STRATOSPHERE Expandable Corpectomy System
- K172199 — ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
- K171031 — CRESCENT Spinal System
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.