Product code LYS— Orthopedic

FDA has cleared 4 devices under product code LYS between 1986 and 1988, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19881 clearance
• 19863 clearances

• Zimmer, Inc.1 clearance
• De Medica Mfg., Inc.1 clearance
• Biodynamic Technologies, Inc.1 clearance
• Aesculap Instruments Corp.1 clearance

Malfunction

1,152

Total

1,152

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K883183 — TRACER BONE MILLDe Medica Mfg., Inc.·1988-10-12
• K860356 — ORTHOBLEND POWERED BONE MILLZimmer, Inc.·1986-07-08
• K861164 — OSTEOMILL BONE GRINDERBiodynamic Technologies, Inc.·1986-05-02
• K860016 — AESCULAP BONE MILLAesculap Instruments Corp.·1986-03-19