510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093719Substantially Equivalent

Pro-Fix Precision Fixation System Model Pfm#, Pfb#, Pft#

Osteogenics Biomedical, Inc., Lubbock TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K093719 is the FDA 510(k) clearance record for PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#, a class II device, cleared for Osteogenics Biomedical, Inc. on under FDA product code DZL (Screw, Fixation, Intraosseous). FDA records list 8 510(k) clearances for Osteogenics Biomedical, Inc., from to . As of , FDA records show no recalls naming K093719.

Clearance record

Decision date
Received
(89 days to decision)
Product code
DZL Screw, Fixation, Intraosseous
Regulation
21 CFR 872.4880
Device class
Class II
Review panel
Dental
Applicant
Osteogenics Biomedical, Inc. 4620 71st St. Bldg. 78-79, Lubbock TX
510(k) summary
Statement
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