510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243889Substantially Equivalent

Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)

Orthocell Limited, Murdoch, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243889 is the FDA 510(k) clearance record for Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm), a class II device, cleared for Orthocell, Ltd. on under FDA product code JXI (Cuff, Nerve). FDA records list 2 510(k) clearances for Orthocell, Ltd., from to . As of , FDA records show no recalls naming K243889.

Clearance record

Decision date
Received
(105 days to decision)
Product code
JXI Cuff, Nerve
Regulation
21 CFR 882.5275
Device class
Class II
Review panel
Neurology
Applicant
Orthocell, Ltd. Bldg. 191, Murdoch University, S. St., Murdoch, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JXI

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