510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050440Substantially Equivalent

Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model Bw-12

Ceremed, Inc., Los Angeles CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050440 is the FDA 510(k) clearance record for AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12, cleared for Ceremed , Inc. on under FDA product code MTJ (Wax, Bone). FDA records list 20 510(k) clearances for Ceremed , Inc., from to . As of , FDA records show no recalls naming K050440.

Clearance record

Decision date
Received
(30 days to decision)
Product code
MTJ Wax, Bone
Device class
Unclassified
Review panel
Unknown
Applicant
Ceremed , Inc. 3643 Lenawee Ave., Los Angeles CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MTJ

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