510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891887Substantially Equivalent

Osteotomes, Various Types

Zinnanti Surgical Instruments, Inc., Chatsworth CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891887 is the FDA 510(k) clearance record for OSTEOTOMES, VARIOUS TYPES, a class I device, cleared for Zinnanti Surgical Instruments, Inc. on under FDA product code GFI (Osteotome, Manual). FDA records list 76 510(k) clearances for Zinnanti Surgical Instruments, Inc., from to . As of , FDA records show no recalls naming K891887.

Clearance record

Decision date
Received
(19 days to decision)
Product code
GFI Osteotome, Manual
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Zinnanti Surgical Instruments, Inc. 21540-B Prairie St., Chatsworth CA
Third party review
No

Clearances, product code GFI

Trailing 12 months

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

FDA records show no clearances under product code GFI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GFI, 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