510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063769Substantially Equivalent

Alpha Bio Bone Fixation Screw System

Alpha-Bio Tec, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063769 is the FDA 510(k) clearance record for ALPHA BIO BONE FIXATION SCREW SYSTEM, a class II device, cleared for Alpha-Bio Tec , Ltd. on under FDA product code DZL (Screw, Fixation, Intraosseous). FDA records list 3 510(k) clearances for Alpha-Bio Tec , Ltd., from to . As of , FDA records show no recalls naming K063769.

Clearance record

Decision date
Received
(100 days to decision)
Product code
DZL Screw, Fixation, Intraosseous
Regulation
21 CFR 872.4880
Device class
Class II
Review panel
Dental
Applicant
Alpha-Bio Tec , Ltd. 5335 Wisconsin Ave. NW, Washington DC
510(k) summary
Summary PDF
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