Atlas FDA

LRZ

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Screwdriver, Surgical
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
1992: 3 · 1993: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERP (K896589)Optik1989-12-27
1.1 SCREWDRIVERS (K872490)Micro-Aire Surgical Instruments, Inc.1987-07-23
STANDARD SCREW DRIVER (K872387)Med-Tool, Inc.1987-07-16

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