510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911552Substantially Equivalent

Anatomic Toe System

Orthopaedic Biosystems, Ltd., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911552 is the FDA 510(k) clearance record for ANATOMIC TOE SYSTEM, cleared for Orthopaedic Biosystems on under FDA product code LZJ (Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained). FDA records list 14 510(k) clearances for Orthopaedic Biosystems, from to . As of , FDA records show no recalls naming K911552.

Clearance record

Decision date
Received
(81 days to decision)
Product code
LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Device class
Unclassified
Review panel
Unknown
Applicant
Orthopaedic Biosystems 701 Palomar Airport Rd., Carlsbad CA
Third party review
No

Clearances, product code LZJ

Trailing 12 months

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

FDA records show no clearances under product code LZJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LZJ, 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