Sky Surgical, LLC

FDA Regulatory Profile

Sky Surgical, LLC appears in FDA public data with 0 recalls, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Dec 5, 2024 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Dec 21, 2023.

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Summary

Total Recalls
0
510(k) Clearances
1
Inspections
2
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 5, 2024Parkville, MODevicesNo Action Indicated (NAI)3030691054
Jul 12, 2010Chesapeake, VABiologicsNo Action Indicated (NAI)3007380418

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K233154SkyOPS™ Orthopedic Plate SystemDec 21, 2023