510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K123745Substantially Equivalent

Sp2 Femoral Locking Nail, Sp2 Tibial Locking Nail

Biomecanica Industria E Comerico de Productos Orto, Aventura FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123745 is the FDA 510(k) clearance record for SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL, a class II device, cleared for Biomecanica Industria E Comerico DE Productos Orto on under FDA product code HSB (Rod, Fixation, Intramedullary And Accessories). FDA records list one 510(k) clearance for Biomecanica Industria E Comerico DE Productos Orto. As of , FDA records show no recalls naming K123745.

Clearance record

Decision date
Received
(109 days to decision)
Product code
HSB Rod, Fixation, Intramedullary And Accessories
Regulation
21 CFR 888.3020
Device class
Class II
Review panel
Orthopedic
Applicant
Biomecanica Industria E Comerico DE Productos Orto 18851 NE 29th Ave., Aventura FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HSB

Trailing 12 months
19 clearances under product code HSB in the twelve months to October 2026, March 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code HSB, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20267
April 20261
May 20262
June 20265
July 20260
August 20260
September 20261
October 20260