NLNClass II
Drills, Burrs, Trephines And Accessories (simple Powered), Reprocessed
Neurology · 21 CFR 882.4310
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
MDR events4All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances1All time
Recent MDR events
4 adverse event reports on file
- DRILL BITJul 6, 2023InjuryMedtronic Powered Surgical SolutionsMW5119198
- STRYKER IBUR 5.0MM COARSE DIAMOND ROUNDMar 2, 2023InjuryStryker InstrumentsMW5115433
- STRYKER CORE 2 NEUROLOGICAL DRILL HLTHCR SYSTEMFeb 23, 2023InjuryStryker InstrumentsMW5115148
- MIDAS REX DISSECTING TOOLFeb 10, 2015MalfunctionMedtronic Powered Surgical Solutions4522835
Event type breakdown
Injury3
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
1 clearances for this product code