510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990353Substantially Equivalent

Stainless Steel Fixation Pins

Bregma International Trading Company, Ltd., Saskatoon, Saskatchewan, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990353 is the FDA 510(k) clearance record for STAINLESS STEEL FIXATION PINS, a class II device, cleared for Bregma International Trading Company , Ltd. on under FDA product code JDW (Pin, Fixation, Threaded). FDA records list 3 510(k) clearances for Bregma International Trading Company , Ltd., from to . As of , FDA records show no recalls naming K990353.

Clearance record

Decision date
Received
(116 days to decision)
Product code
JDW Pin, Fixation, Threaded
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Bregma International Trading Company , Ltd. 214-111 Research Dr., Saskatoon, Saskatchewan, CA
510(k) summary
Statement
Third party review
No

Clearances, product code JDW

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