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510(k) K883183

TRACER BONE MILL by De Medica Mfg., Inc. — Product Code LYS

K883183 is an FDA 510(k) premarket notification submitted by De Medica Mfg., Inc. for the device "TRACER BONE MILL". The FDA issued a decision of Substantially Equivalent on October 12, 1988. The device falls under product code LYS (Bone Mill), a Class I device regulated under 21 CFR 888.4540. De Medica Mfg., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1988
Date Received
July 28, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Mill
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by De Medica Mfg., Inc.

  • K884406 — TRACER HIP PINNING SYSTEM (November 28, 1988)
  • K884407 — TRACER SKELETAL TRACTION PINS (November 28, 1988)

Other clearances for product code LYS

  • K860356 — ORTHOBLEND POWERED BONE MILL (July 8, 1986)
  • K861164 — OSTEOMILL BONE GRINDER (May 2, 1986)
  • K860016 — AESCULAP BONE MILL (March 19, 1986)

FDA data resources