510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K911936Substantially Equivalent

Osteomed Sbf System (Sbf)

Osteomed, Glendale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911936 is the FDA 510(k) clearance record for OSTEOMED SBF SYSTEM (SBF), a class II device, cleared for Osteomed Corp. on under FDA product code DZL (Screw, Fixation, Intraosseous). FDA records list 73 510(k) clearances for Osteomed Corp., from to . As of , FDA records show no recalls naming K911936.

Clearance record

Decision date
Received
(112 days to decision)
Product code
DZL Screw, Fixation, Intraosseous
Regulation
21 CFR 872.4880
Device class
Class II
Review panel
Dental
Applicant
Osteomed Corp. 6062 San Fernando Rd., Glendale CA
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 November 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DZL, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260
November 20260