510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K151762Substantially Equivalent

PediatrOS RigidTack/FlexTack

Merete GmbH, Berlin, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151762 is the FDA 510(k) clearance record for PediatrOS RigidTack/FlexTack, a class II device, cleared for Merete Medical GmbH on under FDA product code JDR (Staple, Fixation, Bone). FDA records list 27 510(k) clearances for MERETE GMBH, from to . As of , FDA records show one recall naming K151762.

Clearance record

Decision date
Received
(182 days to decision)
Product code
JDR Staple, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Merete Medical GmbH Alt-Lankwitz 102, Berlin, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDR

Trailing 12 months
2 clearances under product code JDR 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 JDR, 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 20261
October 20260