510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021953Substantially Equivalent

Mitek Pds/pga Staple

Mitek Worldwide, Norwood MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021953 is the FDA 510(k) clearance record for MITEK PDS/PGA STAPLE, a class II device, cleared for Mitek Worldwide on under FDA product code JDR (Staple, Fixation, Bone). FDA records list 10 510(k) clearances for Mitek Worldwide, from to . As of , FDA records show no recalls naming K021953.

Clearance record

Decision date
Received
(190 days to decision)
Product code
JDR Staple, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Mitek Worldwide 249 Vanderbilt Ave., Norwood MA
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