510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K012413Substantially Equivalent

Macropore Fx, Ps, Ns, Lp

Macropore Biosurgery, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012413 is the FDA 510(k) clearance record for MACROPORE FX, PS, NS, LP, a class II device, cleared for Macropore Biosurgery, Inc. on under FDA product code JEY (Plate, Bone). FDA records list 17 510(k) clearances for Macropore Biosurgery, Inc., from to . As of , FDA records show no recalls naming K012413.

Clearance record

Decision date
Received
(50 days to decision)
Product code
JEY Plate, Bone
Regulation
21 CFR 872.4760
Device class
Class II
Review panel
Dental
Applicant
Macropore Biosurgery, Inc. 6740 Top Gun St., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code JEY

Trailing 12 months
5 clearances under product code JEY in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JEY, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260