510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993493Substantially Equivalent

The Autotac System

BioHorizons Implant Systems Inc, Birmingham AL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993493 is the FDA 510(k) clearance record for THE AUTOTAC SYSTEM, a class II device, cleared for BioHorizons Implant Systems, Inc. on under FDA product code DZL (Screw, Fixation, Intraosseous). FDA records list 41 510(k) clearances for BioHorizons Implant Systems, Inc., from to . As of , FDA records show one recall naming K993493.

Clearance record

Decision date
Received
(84 days to decision)
Product code
DZL Screw, Fixation, Intraosseous
Regulation
21 CFR 872.4880
Device class
Class II
Review panel
Dental
Applicant
BioHorizons Implant Systems, Inc. One Perimeter Park S., Birmingham AL
510(k) summary
Summary
Third party review
No

Clearances, product code DZL

Trailing 12 months
1 clearance under product code DZL in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DZL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260