MICROFUSE PUTTY AND MICROFUSE ST MIS— 510(k) K102392
Substantially EquivalentGlobus Medical, Inc.
FDA 510(k) clearance K102392 for MICROFUSE PUTTY AND MICROFUSE ST MIS, Substantially Equivalent on 2010-12-22. Applicant: Globus Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Globus Medical, Inc.
- Product code
- Code MQV
- Device class
- Class 2
- Regulation
- 21 CFR 888.3045
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Audubon, PA, US
Recent devices under product code MQV
view allMore clearances from Globus Medical, Inc.
view all- K254043 — TRIVANCE Hip Stem
- K262251 — ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)
- K253739 — SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System
- K253401 — SCRIPT Implant System
- K261043 — AUTOBAHN Nailing System
Adverse events under product code MQV
product code MQV- Death
- 6
- Injury
- 435
- Total
- 441
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 K102392
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102392.
Data sourced from openFDA. This site is unofficial and independent of the FDA.