Black Box Medical

FDA Regulatory Profile

Black Box Medical has 0 FDA recalls, 0 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Jul 22, 2020

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances3Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K201751Pedicle Screw SystemJul 22, 2020
K182283FUSE Pedicle Screw SystemOct 23, 2018
K181554Stowe Pedicle Screw SystemJul 27, 2018