510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841626Substantially Equivalent

Punch

Plastafil, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841626 is the FDA 510(k) clearance record for PUNCH, a class I device, cleared for Plastafil, Inc. on under FDA product code HXG (Tamp). FDA records list 13 510(k) clearances for Plastafil, Inc., from to . As of , FDA records show no recalls naming K841626.

Clearance record

Decision date
Received
(130 days to decision)
Product code
HXG Tamp
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Plastafil, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HXG

Trailing 12 months

FDA records hold no clearances under product code HXG in the trailing twelve months.

FDA records show no clearances under product code HXG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HXG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260