510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K112819Substantially Equivalent

Reconstruction Locking Plate and 3.5Mm Locking Screw

Xiamen Double Engline Medical Material Co., Ltd., Shanghai, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112819 is the FDA 510(k) clearance record for RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW, a class II device, cleared for Xiamen Double Engline Medical Material Co., Ltd. on under FDA product code HRS (Plate, Fixation, Bone). FDA records list one 510(k) clearance for Xiamen Double Engline Medical Material Co., Ltd. As of , FDA records show no recalls naming K112819.

Clearance record

Decision date
Received
(79 days to decision)
Product code
HRS Plate, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Xiamen Double Engline Medical Material Co., Ltd. P.O. Box 237-023, Shanghai, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HRS

Trailing 12 months
59 clearances under product code HRS in the twelve months to October 2026, March 2026 the highest month at 13.
Show the numbers
Monthly 510(k) clearances under FDA product code HRS, trailing twelve months
MonthClearances
November 20255
December 20255
January 20264
February 20265
March 202613
April 20266
May 20262
June 20265
July 20265
August 20263
September 20265
October 20261