510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821695Substantially Equivalent

Micro-Aire Replac. Drill Burs for Zimmer

Micro-Aire Surgical Instruments, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821695 is the FDA 510(k) clearance record for MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER, a class I device, cleared for Micro-Aire Surgical Instruments, Inc. on under FDA product code HTT (Burr, Orthopedic). FDA records list 40 510(k) clearances for Micro-Aire Surgical Instruments, Inc., from to . As of , FDA records show no recalls naming K821695.

Clearance record

Decision date
Received
(42 days to decision)
Product code
HTT Burr, Orthopedic
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Micro-Aire Surgical Instruments, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HTT

Trailing 12 months

FDA records hold no clearances under product code HTT in the trailing twelve months.

FDA records show no clearances under product code HTT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HTT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260